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The Application of the Transtheoretical Model to the Frailty Elderly in the Community

Primary Purpose

Frailty

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fitness and Nutrition Program for Seniors
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Frailty focused on measuring frailty, community elderly, Transtheoretical Model, Physical Activity, Health-related Quality of Life, nutritious

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. ≥65 years old
  2. classified as prefrail or frail stage by the Cardiovascular health study (CHS) frailty criteria.
  3. Conscious clear and can comply with study procedures.
  4. Have a device that enables online communication, and having the ability to operate this device. (Experimental group)

Exclusion Criteria:

  1. Diagnosed as unsuitable for physical activity with high risk of acute and chronic diseases, such as neurological impairment, severe cardiovascular or pulmonary disease, persistent joint pain, or severe musculoskeletal impairment or severe musculoskeletal injury, joint or lower extremity surgery within 6 months.
  2. severe visual impairment
  3. institutionalization
  4. Participated in physical activity or nutrition interventional six months ago

Sites / Locations

  • Zhiwuyuan and Fujia Community-Based Care CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fitness and Nutrition Program for Seniors

wait-list

Arm Description

"Fitness and Nutrition Program for Seniors" includes physical activity training, nutrition education- nursing Information, home-based training, and telecare group care (including APP assistance)

Routine care

Outcomes

Primary Outcome Measures

Basic Demographic Health Assessment Form
Number, age, gender, education level, marriage, living conditions, tobacco and alcohol use, economic status, chronic illness history
Cardiovascular health study (CHS) frailty criteria
Frailty criteria comprising weak grip of <26.0 kg in men or <18.0 kg in women; walking slower than 0.8 m/s; self-reported exhaustion on more than 3 days/week; unintentional weight loss of >5.0 kg or 10% during the past year; and physical activity <3.75 MET/h in men or <2.5 MET/h in women (lowest quintile of sex-specific baseline values). People fulfilling three or more criteria were classed as frail, those who met one or two as prefrail, and those with no such deficits as robust.
Cardiovascular health study (CHS) frailty criteria
Frailty criteria comprising weak grip of <26.0 kg in men or <18.0 kg in women; walking slower than 0.8 m/s; self-reported exhaustion on more than 3 days/week; unintentional weight loss of >5.0 kg or 10% during the past year; and physical activity <3.75 MET/h in men or <2.5 MET/h in women (lowest quintile of sex-specific baseline values). People fulfilling three or more criteria were classed as frail, those who met one or two as prefrail, and those with no such deficits as robust.
Cardiovascular health study (CHS) frailty criteria
Frailty criteria comprising weak grip of <26.0 kg in men or <18.0 kg in women; walking slower than 0.8 m/s; self-reported exhaustion on more than 3 days/week; unintentional weight loss of >5.0 kg or 10% during the past year; and physical activity <3.75 MET/h in men or <2.5 MET/h in women (lowest quintile of sex-specific baseline values). People fulfilling three or more criteria were classed as frail, those who met one or two as prefrail, and those with no such deficits as robust.
Physical Activity-Short Physical Performance Battery (SPPB)
SPPB consists of three domains: a Timed 4 m Walk, Balance, and a Chair Sit-to-Stand Test. Each performance measurement was assigned a score from 0 (inability to complete) to 4 (best performance possible). The total of the scores was used to obtain an overall measurement of physical performance. The maximum total score, including all three domains, is 12, and a higher score indicates better physical function.
Physical Activity-Short Physical Performance Battery (SPPB)
SPPB consists of three domains: a Timed 4 m Walk, Balance, and a Chair Sit-to-Stand Test. Each performance measurement was assigned a score from 0 (inability to complete) to 4 (best performance possible). The total of the scores was used to obtain an overall measurement of physical performance. The maximum total score, including all three domains, is 12, and a higher score indicates better physical function.
Physical Activity-Short Physical Performance Battery (SPPB)
SPPB consists of three domains: a Timed 4 m Walk, Balance, and a Chair Sit-to-Stand Test. Each performance measurement was assigned a score from 0 (inability to complete) to 4 (best performance possible). The total of the scores was used to obtain an overall measurement of physical performance. The maximum total score, including all three domains, is 12, and a higher score indicates better physical function.
Physical Activity-Grip Strength
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Physical Activity-Grip Strength
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Physical Activity-Grip Strength
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Physical Activity-Timed Up and Go Test (TUG)
Administration of the TUG requires subjects to stand up from a chair, walk 2.44m, turn around, walk back to the chair, and sit down.
Physical Activity-Timed Up and Go Test (TUG)
Administration of the TUG requires subjects to stand up from a chair, walk 2.44m, turn around, walk back to the chair, and sit down.
Physical Activity-Timed Up and Go Test (TUG)
Administration of the TUG requires subjects to stand up from a chair, walk 2.44m, turn around, walk back to the chair, and sit down.
Health-related Quality of Life
HRQOL was assessed using the Medical Outcomes Survey Short Form-12 questionnaire (SF-12), which consists of eight items representing the following health profile dimensions: general health perception, physical functioning, role functioning-physical, bodily pain, vitality, social functioning, mental health, and role functioning-emotional. Responses are provided using a five- or six-point Likert scale, standardized according to the scoring system. Separate scores are provided for the physical and mental components of health.
Health-related Quality of Life
HRQOL was assessed using the Medical Outcomes Survey Short Form-12 questionnaire (SF-12), which consists of eight items representing the following health profile dimensions: general health perception, physical functioning, role functioning-physical, bodily pain, vitality, social functioning, mental health, and role functioning-emotional. Responses are provided using a five- or six-point Likert scale, standardized according to the scoring system. Separate scores are provided for the physical and mental components of health.
Health-related Quality of Life
HRQOL was assessed using the Medical Outcomes Survey Short Form-12 questionnaire (SF-12), which consists of eight items representing the following health profile dimensions: general health perception, physical functioning, role functioning-physical, bodily pain, vitality, social functioning, mental health, and role functioning-emotional. Responses are provided using a five- or six-point Likert scale, standardized according to the scoring system. Separate scores are provided for the physical and mental components of health.

Secondary Outcome Measures

kinanthropometric measures-BMI
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. We use weight and height will be combined to report BMI in kg/m2.
kinanthropometric measures-BMI
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. We use weight and height will be combined to report BMI in kg/m2.
kinanthropometric measures-BMI
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. We use weight and height will be combined to report BMI in kg/m2.
kinanthropometric measures-upper arm and calf circumference
Upper arm and calf circumference were measured to the nearest 0.1 cm using a flexible but nonstretch measuring tape. Upper arm and calf circumference to measure nutritional status
kinanthropometric measures-upper arm and calf circumference
Upper arm and calf circumference were measured to the nearest 0.1 cm using a flexible but nonstretch measuring tape. Upper arm and calf circumference to measure nutritional status
kinanthropometric measures-upper arm and calf circumference
Upper arm and calf circumference were measured to the nearest 0.1 cm using a flexible but nonstretch measuring tape. Upper arm and calf circumference to measure nutritional status
short from falls efficacy scale international (FES-I)
The 7 items of the FES-I were rated on a 4-point Likert scale with the following possible answers (scores in parentheses): ''not at all'' (1); ''somewhat'' (2); 'fairly' (3); and 'very concerned' (4). If subjects were unable to perform the activity, they were encouraged to respond hypothetically. The range of possible total scores was from 7 to 28, with a high score indicating greater fear of falling.
short from falls efficacy scale international (FES-I)
The 7 items of the FES-I were rated on a 4-point Likert scale with the following possible answers (scores in parentheses): ''not at all'' (1); ''somewhat'' (2); 'fairly' (3); and 'very concerned' (4). If subjects were unable to perform the activity, they were encouraged to respond hypothetically. The range of possible total scores was from 7 to 28, with a high score indicating greater fear of falling.
short from falls efficacy scale international (FES-I)
The 7 items of the FES-I were rated on a 4-point Likert scale with the following possible answers (scores in parentheses): ''not at all'' (1); ''somewhat'' (2); 'fairly' (3); and 'very concerned' (4). If subjects were unable to perform the activity, they were encouraged to respond hypothetically. The range of possible total scores was from 7 to 28, with a high score indicating greater fear of falling.
the visual analog scale (VAS) to measure pain
ranging from "no pain= 0mm" to "unwilling pain= 100mm". Scores were calculated to the nearest millimetre with a ruler.
the visual analog scale (VAS) to measure pain
ranging from "no pain= 0mm" to "unwilling pain= 100mm". Scores were calculated to the nearest millimetre with a ruler.
the visual analog scale (VAS) to measure pain
ranging from "no pain= 0mm" to "unwilling pain= 100mm". Scores were calculated to the nearest millimetre with a ruler.
Instrumental activities of daily living (IADL)
IADL is a 15-item questionnaire that assesses recent participation in functional activity. For each item, participants are required to indicate the extent which four statements reflect their recent participation in an activity. Although responses regarding the four statements varied between items, scores generally ranged from 0 ("never") to 3 ("most days" or "at least once weekly"). Total scores, calculated by summing the item scores, range from 0 to 45.
Instrumental activities of daily living (IADL)
IADL is a 15-item questionnaire that assesses recent participation in functional activity. For each item, participants are required to indicate the extent which four statements reflect their recent participation in an activity. Although responses regarding the four statements varied between items, scores generally ranged from 0 ("never") to 3 ("most days" or "at least once weekly"). Total scores, calculated by summing the item scores, range from 0 to 45.
Instrumental activities of daily living (IADL)
IADL is a 15-item questionnaire that assesses recent participation in functional activity. For each item, participants are required to indicate the extent which four statements reflect their recent participation in an activity. Although responses regarding the four statements varied between items, scores generally ranged from 0 ("never") to 3 ("most days" or "at least once weekly"). Total scores, calculated by summing the item scores, range from 0 to 45.

Full Information

First Posted
January 23, 2022
Last Updated
September 28, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05242549
Brief Title
The Application of the Transtheoretical Model to the Frailty Elderly in the Community
Official Title
Application of the Transtheoretical Model to Physical Activity and Health-related Quality of Life Among the Frailty of the Community Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
As the age structure shows an aging population while facing physical and mental changes among the frailty of the community elderly. Researchers have successively adopted exercise and nutrition strategies for the frail elderly in the community, to improve their physical function, prevent frailty and increase independent functions. There were researches using technology to improve the physical function of the elderly in the community. The transtheoretical model was a comprehensive model of intentional behavior change that incorporates process-oriented variables to explain and predict how and when the elderly change their health behavior including the elderly adoption healthy behavior. Therefore, the investigators use the Trans-Theoretical Model (TTM) to design the "Fitness and Nutrition Program for Seniors" for participants. From improving physical activity and quality of life, then improving the frailty and restoring overall health. The research will be a quasi-experimental design. It is expected to invite 84 frailty elderly from the Community-Based Care Center (42 in the experimental group and 42 in the control group). The investigators use the Trans-Theoretical Model (TTM) as the framework, which includes physical activity training, nutrition education- nursing Information, home-based training, and telecare group care, develop the "Fitness and Nutrition Program for Seniors" for 6 months. The primary outcome includes cardiovascular health study (CHS) frailty criteria, short physical performance battery (SPPB), grip strength, Timed Up and Go Test (TUG), the international physical activity questionnaire (IPAQ), and SF-12. The secondary outcome includes BMI, upper arm and calf circumference to measure nutritional status, short from falls efficacy scale international (FES-I), the visual analog scale (VAS) to measure pain, and instrumental activities of daily living (IADL). The investigator will follow the outcome before the intervention, the third month after the intervention, and the sixth month after the intervention. The collected data were analyzed with a generalized estimation equation model of SPSS version 22. Make the participants develop a habit of physical activity combined with a nutritious diet. Let the elderly reduce frail state, increase physical activity, improve health-related quality of life and improve health-related results.
Detailed Description
The ageing population of the world is an irreversible international situation because of the rapidly increasing number of elderly populations in the 21st century. As the age structure shows an aging population while facing physical and mental changes among the frailty of the community elderly. Helping them prevent disability and promote health has become the focus of current care. Researchers have successively adopted exercise and nutrition strategies for the frail elderly in the community, to improve their physical function, prevent frailty and increase independent functions. The internet was a simple and fast model to care elderly in the community. There were researches using technology to improve the physical function of the elderly in the community. The transtheoretical model was a comprehensive model of intentional behavior change that incorporates process-oriented variables to explain and predict how and when the elderly change their health behavior including the elderly adoption healthy behavior. Therefore, the investigators use the Trans-Theoretical Model (TTM) to design the "Fitness and Nutrition Program for Seniors" for participants, which includes Home-Based physical activity training, nutrition education, and telecare technology. The investigator use the Trans-Theoretical Model (TTM) to analyze the behavior change process of the participants and to explore important factors during the intervention. From improving physical activity and quality of life, then improving the frailty and restoring overall health. The research will be a quasi-experimental pretest-posttest design. It is expected to invite 84 frailty elderly from Community-Based Care Center in Shilin Districts in Taipei City, Taiwan (42 in the experimental group and 42 in the control group). The investigators use the Trans-Theoretical Model (TTM) as the framework, which includes physical activity training, nutrition education-nursing Information, home-based training, and telecare group care, developing the "Fitness and Nutrition Program for Seniors" for 6 months for community-dwelling frail older adults. The participants create motivation to start execution through physical activity and nutritional knowledge and provide the experimental group with online home-based training from the three different stages of TTM behavior change. During the intervention period, the investigators will follow the adherence, satisfaction, behavior change stage every month. The investigators use motivation to improve the self-efficacy of the participants and achieve the result of behavior change. Finally, support the frail participants to enter the maintenance phase. The primary outcome includes frailty status (cardiovascular health study (CHS) frailty criteria), Physical Activity (short physical performance battery (SPPB), grip strength, Timed Up and Go Test (TUG), the international physical activity questionnaire (IPAQ)), and Health-related Quality of Life (SF-12). The secondary outcome includes kinanthropometric measures (BMI, upper arm, and calf circumference to measure nutritional status), short from falls efficacy scale international (FES-I), the visual analog scale (VAS) to measure pain, and instrumental activities of daily living (IADL). The investigators will follow the outcome before the intervention, the third month after the intervention, and the sixth month after the intervention. The collected data were analyzed with a generalized estimation equation model of SPSS version 22. The research hopes to promote the health of the frailty participants through FANS in the community. Make the participants develop a habit of physical activity combined with a nutritious diet. Let the participants reduce frail state, increase physical activity, improve health-related quality of life and improve health-related results, and have a healthy life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
frailty, community elderly, Transtheoretical Model, Physical Activity, Health-related Quality of Life, nutritious

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fitness and Nutrition Program for Seniors
Arm Type
Experimental
Arm Description
"Fitness and Nutrition Program for Seniors" includes physical activity training, nutrition education- nursing Information, home-based training, and telecare group care (including APP assistance)
Arm Title
wait-list
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Behavioral
Intervention Name(s)
Fitness and Nutrition Program for Seniors
Intervention Description
"Fitness and Nutrition Program for Seniors" uses the Trans-Theoretical Model (TTM) as the framework, which includes physical activity training, nutrition education- nursing Information, home-based training, and telecare group care (including APP assistance). Physical activity training comprised muscle training, joint strengthening, and upper and lower limb resistance exercises for older adults who were frail. After administering nutrition education- nursing Information, participants were encouraged to set their own goals to improve their diet. Home-based training and telecare group care depends on the stages of TTM behavior change of the elderly.
Primary Outcome Measure Information:
Title
Basic Demographic Health Assessment Form
Description
Number, age, gender, education level, marriage, living conditions, tobacco and alcohol use, economic status, chronic illness history
Time Frame
baseline, pre-intervention(T0)
Title
Cardiovascular health study (CHS) frailty criteria
Description
Frailty criteria comprising weak grip of <26.0 kg in men or <18.0 kg in women; walking slower than 0.8 m/s; self-reported exhaustion on more than 3 days/week; unintentional weight loss of >5.0 kg or 10% during the past year; and physical activity <3.75 MET/h in men or <2.5 MET/h in women (lowest quintile of sex-specific baseline values). People fulfilling three or more criteria were classed as frail, those who met one or two as prefrail, and those with no such deficits as robust.
Time Frame
baseline, pre-intervention(T0)
Title
Cardiovascular health study (CHS) frailty criteria
Description
Frailty criteria comprising weak grip of <26.0 kg in men or <18.0 kg in women; walking slower than 0.8 m/s; self-reported exhaustion on more than 3 days/week; unintentional weight loss of >5.0 kg or 10% during the past year; and physical activity <3.75 MET/h in men or <2.5 MET/h in women (lowest quintile of sex-specific baseline values). People fulfilling three or more criteria were classed as frail, those who met one or two as prefrail, and those with no such deficits as robust.
Time Frame
three months after intervention(T1)
Title
Cardiovascular health study (CHS) frailty criteria
Description
Frailty criteria comprising weak grip of <26.0 kg in men or <18.0 kg in women; walking slower than 0.8 m/s; self-reported exhaustion on more than 3 days/week; unintentional weight loss of >5.0 kg or 10% during the past year; and physical activity <3.75 MET/h in men or <2.5 MET/h in women (lowest quintile of sex-specific baseline values). People fulfilling three or more criteria were classed as frail, those who met one or two as prefrail, and those with no such deficits as robust.
Time Frame
six months after intervention(T2)
Title
Physical Activity-Short Physical Performance Battery (SPPB)
Description
SPPB consists of three domains: a Timed 4 m Walk, Balance, and a Chair Sit-to-Stand Test. Each performance measurement was assigned a score from 0 (inability to complete) to 4 (best performance possible). The total of the scores was used to obtain an overall measurement of physical performance. The maximum total score, including all three domains, is 12, and a higher score indicates better physical function.
Time Frame
baseline, pre-intervention(T0)
Title
Physical Activity-Short Physical Performance Battery (SPPB)
Description
SPPB consists of three domains: a Timed 4 m Walk, Balance, and a Chair Sit-to-Stand Test. Each performance measurement was assigned a score from 0 (inability to complete) to 4 (best performance possible). The total of the scores was used to obtain an overall measurement of physical performance. The maximum total score, including all three domains, is 12, and a higher score indicates better physical function.
Time Frame
three months after intervention(T1)
Title
Physical Activity-Short Physical Performance Battery (SPPB)
Description
SPPB consists of three domains: a Timed 4 m Walk, Balance, and a Chair Sit-to-Stand Test. Each performance measurement was assigned a score from 0 (inability to complete) to 4 (best performance possible). The total of the scores was used to obtain an overall measurement of physical performance. The maximum total score, including all three domains, is 12, and a higher score indicates better physical function.
Time Frame
six months after intervention(T2)
Title
Physical Activity-Grip Strength
Description
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Time Frame
baseline, pre-intervention(T0)
Title
Physical Activity-Grip Strength
Description
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Time Frame
three months after intervention(T1)
Title
Physical Activity-Grip Strength
Description
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Time Frame
six months after intervention(T2)
Title
Physical Activity-Timed Up and Go Test (TUG)
Description
Administration of the TUG requires subjects to stand up from a chair, walk 2.44m, turn around, walk back to the chair, and sit down.
Time Frame
baseline, pre-intervention(T0)
Title
Physical Activity-Timed Up and Go Test (TUG)
Description
Administration of the TUG requires subjects to stand up from a chair, walk 2.44m, turn around, walk back to the chair, and sit down.
Time Frame
three month after intervention(T1)
Title
Physical Activity-Timed Up and Go Test (TUG)
Description
Administration of the TUG requires subjects to stand up from a chair, walk 2.44m, turn around, walk back to the chair, and sit down.
Time Frame
six month after intervention(T2)
Title
Health-related Quality of Life
Description
HRQOL was assessed using the Medical Outcomes Survey Short Form-12 questionnaire (SF-12), which consists of eight items representing the following health profile dimensions: general health perception, physical functioning, role functioning-physical, bodily pain, vitality, social functioning, mental health, and role functioning-emotional. Responses are provided using a five- or six-point Likert scale, standardized according to the scoring system. Separate scores are provided for the physical and mental components of health.
Time Frame
baseline, pre-intervention(T0)
Title
Health-related Quality of Life
Description
HRQOL was assessed using the Medical Outcomes Survey Short Form-12 questionnaire (SF-12), which consists of eight items representing the following health profile dimensions: general health perception, physical functioning, role functioning-physical, bodily pain, vitality, social functioning, mental health, and role functioning-emotional. Responses are provided using a five- or six-point Likert scale, standardized according to the scoring system. Separate scores are provided for the physical and mental components of health.
Time Frame
three months after intervention(T1)
Title
Health-related Quality of Life
Description
HRQOL was assessed using the Medical Outcomes Survey Short Form-12 questionnaire (SF-12), which consists of eight items representing the following health profile dimensions: general health perception, physical functioning, role functioning-physical, bodily pain, vitality, social functioning, mental health, and role functioning-emotional. Responses are provided using a five- or six-point Likert scale, standardized according to the scoring system. Separate scores are provided for the physical and mental components of health.
Time Frame
six months after intervention(T2)
Secondary Outcome Measure Information:
Title
kinanthropometric measures-BMI
Description
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. We use weight and height will be combined to report BMI in kg/m2.
Time Frame
baseline, pre-intervention(T0)
Title
kinanthropometric measures-BMI
Description
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. We use weight and height will be combined to report BMI in kg/m2.
Time Frame
three months after intervention(T1)
Title
kinanthropometric measures-BMI
Description
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. We use weight and height will be combined to report BMI in kg/m2.
Time Frame
six months after intervention(T2)
Title
kinanthropometric measures-upper arm and calf circumference
Description
Upper arm and calf circumference were measured to the nearest 0.1 cm using a flexible but nonstretch measuring tape. Upper arm and calf circumference to measure nutritional status
Time Frame
baseline, pre-intervention(T0)
Title
kinanthropometric measures-upper arm and calf circumference
Description
Upper arm and calf circumference were measured to the nearest 0.1 cm using a flexible but nonstretch measuring tape. Upper arm and calf circumference to measure nutritional status
Time Frame
three months after intervention(T1)
Title
kinanthropometric measures-upper arm and calf circumference
Description
Upper arm and calf circumference were measured to the nearest 0.1 cm using a flexible but nonstretch measuring tape. Upper arm and calf circumference to measure nutritional status
Time Frame
six months after intervention(T2)
Title
short from falls efficacy scale international (FES-I)
Description
The 7 items of the FES-I were rated on a 4-point Likert scale with the following possible answers (scores in parentheses): ''not at all'' (1); ''somewhat'' (2); 'fairly' (3); and 'very concerned' (4). If subjects were unable to perform the activity, they were encouraged to respond hypothetically. The range of possible total scores was from 7 to 28, with a high score indicating greater fear of falling.
Time Frame
baseline, pre-intervention(T0)
Title
short from falls efficacy scale international (FES-I)
Description
The 7 items of the FES-I were rated on a 4-point Likert scale with the following possible answers (scores in parentheses): ''not at all'' (1); ''somewhat'' (2); 'fairly' (3); and 'very concerned' (4). If subjects were unable to perform the activity, they were encouraged to respond hypothetically. The range of possible total scores was from 7 to 28, with a high score indicating greater fear of falling.
Time Frame
three months after intervention(T1)
Title
short from falls efficacy scale international (FES-I)
Description
The 7 items of the FES-I were rated on a 4-point Likert scale with the following possible answers (scores in parentheses): ''not at all'' (1); ''somewhat'' (2); 'fairly' (3); and 'very concerned' (4). If subjects were unable to perform the activity, they were encouraged to respond hypothetically. The range of possible total scores was from 7 to 28, with a high score indicating greater fear of falling.
Time Frame
six months after intervention(T2)
Title
the visual analog scale (VAS) to measure pain
Description
ranging from "no pain= 0mm" to "unwilling pain= 100mm". Scores were calculated to the nearest millimetre with a ruler.
Time Frame
baseline, pre-intervention(T0)
Title
the visual analog scale (VAS) to measure pain
Description
ranging from "no pain= 0mm" to "unwilling pain= 100mm". Scores were calculated to the nearest millimetre with a ruler.
Time Frame
three months after intervention(T1)
Title
the visual analog scale (VAS) to measure pain
Description
ranging from "no pain= 0mm" to "unwilling pain= 100mm". Scores were calculated to the nearest millimetre with a ruler.
Time Frame
six months after intervention(T2)
Title
Instrumental activities of daily living (IADL)
Description
IADL is a 15-item questionnaire that assesses recent participation in functional activity. For each item, participants are required to indicate the extent which four statements reflect their recent participation in an activity. Although responses regarding the four statements varied between items, scores generally ranged from 0 ("never") to 3 ("most days" or "at least once weekly"). Total scores, calculated by summing the item scores, range from 0 to 45.
Time Frame
baseline, pre-intervention(T0)
Title
Instrumental activities of daily living (IADL)
Description
IADL is a 15-item questionnaire that assesses recent participation in functional activity. For each item, participants are required to indicate the extent which four statements reflect their recent participation in an activity. Although responses regarding the four statements varied between items, scores generally ranged from 0 ("never") to 3 ("most days" or "at least once weekly"). Total scores, calculated by summing the item scores, range from 0 to 45.
Time Frame
three months after intervention(T1)
Title
Instrumental activities of daily living (IADL)
Description
IADL is a 15-item questionnaire that assesses recent participation in functional activity. For each item, participants are required to indicate the extent which four statements reflect their recent participation in an activity. Although responses regarding the four statements varied between items, scores generally ranged from 0 ("never") to 3 ("most days" or "at least once weekly"). Total scores, calculated by summing the item scores, range from 0 to 45.
Time Frame
six months after intervention(T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥65 years old classified as prefrail or frail stage by the Cardiovascular health study (CHS) frailty criteria. Conscious clear and can comply with study procedures. Have a device that enables online communication, and having the ability to operate this device. (Experimental group) Exclusion Criteria: Diagnosed as unsuitable for physical activity with high risk of acute and chronic diseases, such as neurological impairment, severe cardiovascular or pulmonary disease, persistent joint pain, or severe musculoskeletal impairment or severe musculoskeletal injury, joint or lower extremity surgery within 6 months. severe visual impairment institutionalization Participated in physical activity or nutrition interventional six months ago
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Jung Hsieh, PhD
Phone
+886(2)2822-7101
Ext
3135
Email
chiajung@ntunhs.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Shan LI, master
Phone
+886 920769124
Email
phli2@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Jung Hsieh, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhiwuyuan and Fujia Community-Based Care Center
City
Taipei
State/Province
Shilin Districts
ZIP/Postal Code
111
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunmin Liao, Undertaker
Phone
+886 228342158
First Name & Middle Initial & Last Name & Degree
Wenzong Xiao, Undertaker
Phone
+886 228350489

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Links:
URL
http://www.ifa-copenhagen-summit.com/wp-content/uploads/2016/04/Copenhagen-Summit-Final-Report.pdf
Description
Reablement and older people, Final report of the International Federation on Aging Copenhagen Summit

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The Application of the Transtheoretical Model to the Frailty Elderly in the Community

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