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Influence of Sit Muscle Strength Training and Game on Elderly

Primary Purpose

Aging, Physical Disability, Dementia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Sit muscle strength training
Game training
Sitting strength + game training
Health education
Sponsored by
Central Taiwan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aging

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

1.Inclusion Criteria:

  1. Elderly persons between the age of 60 and 100 who take long-term care of the relevant units do not have limited sports
  2. stable condition with sufficient physical strength: at least one hour sitting in the wheelchair or bed edge.
  3. Subjects in the past month tended to live in static state (less than 150 minutes of exercise time per week).

2.Exclusion Criteria:

  1. Serious illness / unstable status (judged by medical staff), such as serious cardiopulmonary diseases, severe malignant tumor (assessment from medical personnel), severe malnutrition (mini nutrition assessment scale 0-7 points).
  2. Unstable weight over the past six months (> ± 4 kg).

Sites / Locations

  • Central Taiwan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Sit muscle strength training

Game training

Sitting strength + game training

Health education

Arm Description

Sit muscle strength training using a sand bag grip ball conducted twice a week. Each exercise session will begin and end with a 5-15 minute warm-up and cool-down routine. The exercise program consists of 20-40 minute chair-based resistance exercises.

Game training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes.

Sitting strength training (using sandbag training conducted twice a week) and game training (such as ball activities and clay courses) conducted twice a week).

Health education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe.

Outcomes

Primary Outcome Measures

change from baseline body composition at 4 months and 8 months
bioelectrical impedance analysis for body composition
change from baseline body function (ADL)at 4 months and 8 months
The barthel index for activities of daily living
change from baseline muscle strength at 4 months and 8 months
lb or kg
change from baseline quality of life at 4 months and 8 months
WHOQOL-BREF scale for quality of life measurement from world health organization questionnaire.
change from baseline scale of quality of life at 4 months and 8 months
EQ-5D (5 dimentions) scale for quality of life measurement from the EuroQol group.
change from baseline quality of life(dementia) at 4 months and 8 months
QUALIDEM is a dementia-specific quality of life instrument.
change from baseline questionnaire of quality of life at 4 months and 8 months
PERSONAL WELLBEING INDEX for quality of life measurement.
change from baseline body weight at 4 months and 8 months
kg
change from baseline body height at 4 months and 8 months
cm
change from baseline body function(IADL) at 4 months and 8 months
Instrumental Activities of Daily Living for body function
change from baseline body function at 4 months and 8 months
Body Awareness Rating Scale for body function

Secondary Outcome Measures

change from baseline cognition at 4 months and 8 months
The Clinical dementia rating scale (CDR) for memory, orientation, problem solving, community affairs, hobbies and personal care measurement.
change from baseline behavior at 4 months and 8 months
The Cohen-Mansfield agitation inventory for aggressive behavior, physically nonaggressive behavior, verbally agitated behavior measurements.
change from baseline depression at 4 months and 8 months
cornell scale for depression measurement: a score >10 probably major depressive episode ,A score >18 denote major depressive episode
change from baseline sleep(PSQI) at 4 months and 8 months
The pittsburgh sleep quality index for sleep time and efficiency.
change from baseline mental and cognition at 4 months and 8 months
Alzheimer's disease assessment scale(ADAS) for cognitive behavior, recall, recognition, constructional praxis measurement.
change from baseline mental at 4 months and 8 months
Clock test for constructional measurement.
change from baseline sleep at 4 months and 8 months
The actigraph for sleep time and efficiency.

Full Information

First Posted
December 9, 2017
Last Updated
June 30, 2022
Sponsor
Central Taiwan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03411382
Brief Title
Influence of Sit Muscle Strength Training and Game on Elderly
Official Title
Influence of Sit Muscle Strength Training and Game on Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
January 4, 2021 (Actual)
Study Completion Date
January 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Taiwan University of Science and Technology

4. Oversight

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

5. Study Description

Brief Summary
Objective: The study aims to understand the physical function, body composition, mental state, behavior, depression, and life quality change of the elderly in a long-term care before and after the intervention. Four interventional activities are sitting strength training, games, sitting strength training with games, and health education.
Detailed Description
Expected results: (1) The program will facilitate arrange activities that are beneficial to the body and mind, activate bodily functions, and promote the quality of life of the elderly in Taiwan. (2) The program can compare the effectiveness of different trainings for the elderly and provide a reference for future implementation planning. (3) Evidence of the empirical study of this program can provide future comparisons with other domestic and foreign studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Physical Disability, Dementia, Elderly

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sit muscle strength training
Arm Type
Experimental
Arm Description
Sit muscle strength training using a sand bag grip ball conducted twice a week. Each exercise session will begin and end with a 5-15 minute warm-up and cool-down routine. The exercise program consists of 20-40 minute chair-based resistance exercises.
Arm Title
Game training
Arm Type
Experimental
Arm Description
Game training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes.
Arm Title
Sitting strength + game training
Arm Type
Experimental
Arm Description
Sitting strength training (using sandbag training conducted twice a week) and game training (such as ball activities and clay courses) conducted twice a week).
Arm Title
Health education
Arm Type
Placebo Comparator
Arm Description
Health education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe.
Intervention Type
Other
Intervention Name(s)
Sit muscle strength training
Intervention Description
Sit muscle strength training using a sand bag grip ball conducted twice a week. Each exercise session will begin and end with a 5-15 minute warm-up and cool-down routine. The exercise program consists of 20-40 minute chair-based resistance exercises.
Intervention Type
Other
Intervention Name(s)
Game training
Intervention Description
Game training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes.
Intervention Type
Other
Intervention Name(s)
Sitting strength + game training
Intervention Description
Sitting strength training (using sandbag training conducted twice a week) and game training (such as ball activities and clay courses) conducted twice a week).
Intervention Type
Other
Intervention Name(s)
Health education
Intervention Description
Health education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe.
Primary Outcome Measure Information:
Title
change from baseline body composition at 4 months and 8 months
Description
bioelectrical impedance analysis for body composition
Time Frame
baseline, 4 months, 8 months
Title
change from baseline body function (ADL)at 4 months and 8 months
Description
The barthel index for activities of daily living
Time Frame
baseline, 4 months, 8 months
Title
change from baseline muscle strength at 4 months and 8 months
Description
lb or kg
Time Frame
baseline, 4 months, 8 months
Title
change from baseline quality of life at 4 months and 8 months
Description
WHOQOL-BREF scale for quality of life measurement from world health organization questionnaire.
Time Frame
baseline, 4 months, 8 months
Title
change from baseline scale of quality of life at 4 months and 8 months
Description
EQ-5D (5 dimentions) scale for quality of life measurement from the EuroQol group.
Time Frame
baseline, 4 months, 8 months
Title
change from baseline quality of life(dementia) at 4 months and 8 months
Description
QUALIDEM is a dementia-specific quality of life instrument.
Time Frame
baseline, 4 months, 8 months
Title
change from baseline questionnaire of quality of life at 4 months and 8 months
Description
PERSONAL WELLBEING INDEX for quality of life measurement.
Time Frame
baseline, 4 months, 8 months
Title
change from baseline body weight at 4 months and 8 months
Description
kg
Time Frame
baseline, 4 months, 8 months
Title
change from baseline body height at 4 months and 8 months
Description
cm
Time Frame
baseline, 4 months, 8 months
Title
change from baseline body function(IADL) at 4 months and 8 months
Description
Instrumental Activities of Daily Living for body function
Time Frame
baseline, 4 months, 8 months
Title
change from baseline body function at 4 months and 8 months
Description
Body Awareness Rating Scale for body function
Time Frame
baseline, 4 months, 8 months
Secondary Outcome Measure Information:
Title
change from baseline cognition at 4 months and 8 months
Description
The Clinical dementia rating scale (CDR) for memory, orientation, problem solving, community affairs, hobbies and personal care measurement.
Time Frame
baseline, 4 months, 8 months
Title
change from baseline behavior at 4 months and 8 months
Description
The Cohen-Mansfield agitation inventory for aggressive behavior, physically nonaggressive behavior, verbally agitated behavior measurements.
Time Frame
baseline, 4 months, 8 months
Title
change from baseline depression at 4 months and 8 months
Description
cornell scale for depression measurement: a score >10 probably major depressive episode ,A score >18 denote major depressive episode
Time Frame
baseline, 4 months, 8 months
Title
change from baseline sleep(PSQI) at 4 months and 8 months
Description
The pittsburgh sleep quality index for sleep time and efficiency.
Time Frame
baseline, 4 months, 8 months
Title
change from baseline mental and cognition at 4 months and 8 months
Description
Alzheimer's disease assessment scale(ADAS) for cognitive behavior, recall, recognition, constructional praxis measurement.
Time Frame
baseline, 4 months, 8 months
Title
change from baseline mental at 4 months and 8 months
Description
Clock test for constructional measurement.
Time Frame
baseline, 4 months, 8 months
Title
change from baseline sleep at 4 months and 8 months
Description
The actigraph for sleep time and efficiency.
Time Frame
baseline, 4 months, 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
1.Inclusion Criteria: Elderly persons between the age of 60 and 100 who take long-term care of the relevant units do not have limited sports stable condition with sufficient physical strength: at least one hour sitting in the wheelchair or bed edge. Subjects in the past month tended to live in static state (less than 150 minutes of exercise time per week). 2.Exclusion Criteria: Serious illness / unstable status (judged by medical staff), such as serious cardiopulmonary diseases, severe malignant tumor (assessment from medical personnel), severe malnutrition (mini nutrition assessment scale 0-7 points). Unstable weight over the past six months (> ± 4 kg).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Ching Chiu, Phd
Organizational Affiliation
Instructor of Central Taiwan University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Central Taiwan University of Science and Technology
City
Taichung
ZIP/Postal Code
406
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of Sit Muscle Strength Training and Game on Elderly

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