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Evaluation of a Frailty Intervention Program in Hong Kong

Primary Purpose

Frailty

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Frailty intervention program
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • People aged 50 years or older;
  • FRAIL score ≥ 1, and thus are considered pre-frail / frail;
  • Chinese origin;
  • Normally reside in Hong Kong;
  • Could speak and understand Chinese;
  • Willing to follow the study procedures.

Exclusion Criteria:

  • Live in a residential aged care facility;
  • Recent (i.e. past 3 months) or concurrent participation in any clinical trial or exercise and/or cognitive and/or dietary intervention program;
  • With medical advice or conditions prohibiting exercise or medical conditions that precluded safe participation in an exercise program;
  • With any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study.

Sites / Locations

  • Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Frailty intervention program

Control group

Arm Description

There will be 2 sessions per week for 12 weeks. Each session includes 1 hour exercise (including 5-10 minute warm-up and cool-down routine, 20-30 minute chair-based resistance exercises using Thera-Bands for muscle groups in both the upper and lower body, and 20-30 minutes aerobic exercises); and 1 hour game training using computer video games, board games and card games. Nutrition education will be given to the subjects based on their weight status. The 1st level of nutrition information (healthy eating tips for frailty prevention and management) will be given to all subjects on regular basis during the 12-week study period via short videos, text messages or Whatsapp reminders. On top of the 1st level nutrition information, 3 nutrition heath talks (1-1.5 hours per talk) about weight management will be given to those with BMI >=25 kg/m2, and/or waist circumference >=90 cm (male) or >=80 cm (female) during the 12-week study period.

Subjects in the control group will be asked to maintain their usual diet and physical activity patterns over the 12 weeks.

Outcomes

Primary Outcome Measures

Change in gait speed
This outcome will be measured using the 6-meter walk test.

Secondary Outcome Measures

Frailty status
Frailty status (i.e. robust, prefrail or frail) measured using the frailty scale (FRAIL) in which unabbreviated scale name is unavailable for this scale. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) and represent robust (0), pre-frail (1-2), and frail (3-5) health status.
Handgrip strength
Handgrip strength will be measured using a dynamometer.
5 chair stands
Muscle endurance in the lower extremities - Participant will be required to rise from a chair a total of 5 times, as quickly as they could, with arms across their chest. The amount of time required to complete all 5 repetitions will be recorded.
Balance test
Participant will be required to stand with different postures and maintain balance for 10 seconds each. The number of completed posture will be used for analysis.
Cognitive performance
Frontal Assessment Battery will be used to assess executive function. Total score is a maximum of 18, higher scores indicating better performance.
Dietary intake
Dietary habits and patterns over the past week will be assessed using a questionnaire designed by the research team based on the questionnaire used in the Hong Kong Child Health Survey (Department of Health, 2009) with modifications.
Nutritional status
This outcome will be assessed using Mini-Nutritional Assessment Short Form (MNA-SF). The total score of the MNA-SF ranges from 0-14 points, with 0-7 points indicate malnourished, 8-11 points as at risk of malnutrition and 12-14 points as normal nutritional status.
Physical activity
This outcome will be assessed using a validated Chinese version of the International Physical Activity Questionnaire (IPAQ-C). Metabolic equivalent for Task (MET)-minutes/week values for walking, moderate-intensity activities, vigorous-intensity activities, and total physical activities will be calculated for data analysis. Higher MET-minutes/week value represents higher amount of energy expended in carrying out physical activity.
Self-rated health
This outcome will be elicited by a single question, "Generally speaking, how is your health: excellent, very good, good, fair, or poor?" .
Life satisfaction
This outcome will be assessed by the subjects' response to the question "Are you satisfied with life?", using a 0 to 10-point linear scale. Higher point represents better self-rated life satisfaction.
Self-efficacy of chronic disease management
This outcome will be assessed using a validated Chinese version of short-form Chronic Disease Self-Efficacy Scales (CDSES) for older adults. Each item will be rated by the subjects on a scale from 1-10. The total score of the short-form CDSES is the mean of the six items, with higher score indicates better self-efficacy.
Views towards the frailty intervention program
Participants in the intervention group will be invited to share their experience and opinion in focus groups (of 1 to 1.5 hours duration).

Full Information

First Posted
December 23, 2019
Last Updated
May 25, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04216056
Brief Title
Evaluation of a Frailty Intervention Program in Hong Kong
Official Title
Evaluation of a Frailty Intervention Program in Hong Kong: A Pre-Post Study and a Focus Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

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
The present study aims to compare the pre-post effect of a frailty intervention program with exercise, nutrition, cognitive and social components with a control group without such program on improving gait speed and frailty in community-dwelling Chinese adults aged 50 and above who are pre-frail or frail using the FRAIL scale, and to obtain their views towards the frailty intervention program. The investigators hypothesized that the frailty intervention program will result in improvements regarding frailty, mobility, weight status and other health outcomes. This study will be a non-randomized controlled study using a controlled before-and-after study design. Eligible subjects will be assigned to one of the two groups: frailty intervention program, or control group without any intervention, over 12 weeks. A total of 152 subjects (76 per group) will be recruited. A sub-sample of 25 subjects from the intervention group will be invited to share their experience and opinion in focus groups.
Detailed Description
A 30-month trial, which will be divided into three phases, namely study preparation and subject recruitment (6 months), data collection (18 months), and data entry and analysis (6 months), will be conducted. This study will be a non-randomized controlled study using a controlled before-and-after study design. Eligible subjects will receive a baseline assessment in the community facilities. After that, eligible subjects will be assigned to one of the two groups: frailty intervention program, or control group without any intervention, over 12 weeks. Subjects in the frailty intervention program will be invited to participate in the following components: exercise, game training and nutrition education; while subjects in the control group will be asked to maintain their usual diet and physical activity patterns. A total of 152 subjects (76 per group) will be recruited. Outcome measurements will be collected at two time points, namely baseline (T0), and 12 (T1) weeks. The primary outcome will be the improvement in gait speed over 12 weeks. Secondary outcomes will include the change in the following parameters over 12 weeks: frailty, handgrip strength, 5 chair stands, balance test, Frontal Assessment Battery, dietary intake, nutritional status, physical activity, self-rated health, life satisfaction and self-efficacy of chronic disease management. In a sub-sample of 25 subjects from the intervention group, their views towards the frailty intervention program will be obtained from the focus group study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Frailty intervention program
Arm Type
Experimental
Arm Description
There will be 2 sessions per week for 12 weeks. Each session includes 1 hour exercise (including 5-10 minute warm-up and cool-down routine, 20-30 minute chair-based resistance exercises using Thera-Bands for muscle groups in both the upper and lower body, and 20-30 minutes aerobic exercises); and 1 hour game training using computer video games, board games and card games. Nutrition education will be given to the subjects based on their weight status. The 1st level of nutrition information (healthy eating tips for frailty prevention and management) will be given to all subjects on regular basis during the 12-week study period via short videos, text messages or Whatsapp reminders. On top of the 1st level nutrition information, 3 nutrition heath talks (1-1.5 hours per talk) about weight management will be given to those with BMI >=25 kg/m2, and/or waist circumference >=90 cm (male) or >=80 cm (female) during the 12-week study period.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subjects in the control group will be asked to maintain their usual diet and physical activity patterns over the 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Frailty intervention program
Intervention Description
There will be 2 sessions per week for 12 weeks. Each session includes 1 hour exercise (including 5-10 minute warm-up and cool-down routine, 20-30 minute chair-based resistance exercises using Thera-Bands for muscle groups in both the upper and lower body, and 20-30 minutes aerobic exercises); and 1 hour game training using computer video games, board games and card games. Nutrition education will be given to the subjects based on their weight status. The 1st level of nutrition information (healthy eating tips for frailty prevention and management) will be given to all subjects on regular basis during the 12-week study period via short videos, text messages or Whatsapp reminders. On top of the 1st level nutrition information, 3 nutrition heath talks (1-1.5 hours per talk) about weight management will be given to those with BMI >=25 kg/m2, and/or waist circumference >=90 cm (male) or >=80 cm (female) during the 12-week study period.
Primary Outcome Measure Information:
Title
Change in gait speed
Description
This outcome will be measured using the 6-meter walk test.
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Frailty status
Description
Frailty status (i.e. robust, prefrail or frail) measured using the frailty scale (FRAIL) in which unabbreviated scale name is unavailable for this scale. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) and represent robust (0), pre-frail (1-2), and frail (3-5) health status.
Time Frame
baseline, 12 weeks
Title
Handgrip strength
Description
Handgrip strength will be measured using a dynamometer.
Time Frame
baseline, 12 weeks
Title
5 chair stands
Description
Muscle endurance in the lower extremities - Participant will be required to rise from a chair a total of 5 times, as quickly as they could, with arms across their chest. The amount of time required to complete all 5 repetitions will be recorded.
Time Frame
baseline, 12 weeks
Title
Balance test
Description
Participant will be required to stand with different postures and maintain balance for 10 seconds each. The number of completed posture will be used for analysis.
Time Frame
baseline, 12 weeks
Title
Cognitive performance
Description
Frontal Assessment Battery will be used to assess executive function. Total score is a maximum of 18, higher scores indicating better performance.
Time Frame
baseline, 12 weeks
Title
Dietary intake
Description
Dietary habits and patterns over the past week will be assessed using a questionnaire designed by the research team based on the questionnaire used in the Hong Kong Child Health Survey (Department of Health, 2009) with modifications.
Time Frame
baseline, 12 weeks
Title
Nutritional status
Description
This outcome will be assessed using Mini-Nutritional Assessment Short Form (MNA-SF). The total score of the MNA-SF ranges from 0-14 points, with 0-7 points indicate malnourished, 8-11 points as at risk of malnutrition and 12-14 points as normal nutritional status.
Time Frame
baseline, 12 weeks
Title
Physical activity
Description
This outcome will be assessed using a validated Chinese version of the International Physical Activity Questionnaire (IPAQ-C). Metabolic equivalent for Task (MET)-minutes/week values for walking, moderate-intensity activities, vigorous-intensity activities, and total physical activities will be calculated for data analysis. Higher MET-minutes/week value represents higher amount of energy expended in carrying out physical activity.
Time Frame
baseline, 12 weeks
Title
Self-rated health
Description
This outcome will be elicited by a single question, "Generally speaking, how is your health: excellent, very good, good, fair, or poor?" .
Time Frame
baseline, 12 weeks
Title
Life satisfaction
Description
This outcome will be assessed by the subjects' response to the question "Are you satisfied with life?", using a 0 to 10-point linear scale. Higher point represents better self-rated life satisfaction.
Time Frame
baseline, 12 weeks
Title
Self-efficacy of chronic disease management
Description
This outcome will be assessed using a validated Chinese version of short-form Chronic Disease Self-Efficacy Scales (CDSES) for older adults. Each item will be rated by the subjects on a scale from 1-10. The total score of the short-form CDSES is the mean of the six items, with higher score indicates better self-efficacy.
Time Frame
baseline, 12 weeks
Title
Views towards the frailty intervention program
Description
Participants in the intervention group will be invited to share their experience and opinion in focus groups (of 1 to 1.5 hours duration).
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Weight
Description
Weight in kilogram measured using standardized method.
Time Frame
baseline, 12 weeks
Title
Height
Description
Height in centimeter measured using standardized method.
Time Frame
baseline, 12 weeks
Title
Waist circumference
Description
Waist circumference in centimeter measured using standardized method.
Time Frame
baseline, 12 weeks
Title
Systolic blood pressure
Description
Systolic blood pressure in mmHg measured using standardized method.
Time Frame
baseline, 12 weeks
Title
Diastolic blood pressure
Description
Diastolic blood pressure in mmHg measured using standardized method.
Time Frame
baseline, 12 weeks
Title
Fat mass percentage
Description
This outcome will be measured using bioelectrical impedance analysis (BIA).
Time Frame
baseline, 12 weeks
Title
Fat free mass percentage
Description
This outcome will be measured using bioelectrical impedance analysis (BIA).
Time Frame
baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People aged 50 years or older; FRAIL score ≥ 1, and thus are considered pre-frail / frail; Chinese origin; Normally reside in Hong Kong; Could speak and understand Chinese; Willing to follow the study procedures. Exclusion Criteria: Live in a residential aged care facility; Recent (i.e. past 3 months) or concurrent participation in any clinical trial or exercise and/or cognitive and/or dietary intervention program; With medical advice or conditions prohibiting exercise or medical conditions that precluded safe participation in an exercise program; With any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Woo, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Frailty Intervention Program in Hong Kong

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