Influence of Sit Muscle Strength Training and Game on Elderly

Study Overview
=================
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.

Official Title
-----------------
Influence of Sit Muscle Strength Training and Game on Elderly

Conditions
-----------------
Aging, Physical Disability, Dementia, Elderly

Intervention / Treatment
-----------------
* Other: Sit muscle strength training
* Other: Game training
* Other: Sitting strength + game training
* Other: Health education


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sit muscle strength training<br>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. | Other: Sit muscle strength training<br>* 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.<br>|
| Experimental: Game training<br>Game training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes. | Other: Game training<br>* Game training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes.<br>|
| Experimental: Sitting strength + game training<br>Sitting strength training (using sandbag training conducted twice a week) and game training (such as ball activities and clay courses) conducted twice a week). | Other: Sitting strength + game training<br>* Sitting strength training (using sandbag training conducted twice a week) and game training (such as ball activities and clay courses) conducted twice a week).<br>|
| Placebo Comparator: Health education<br>Health education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe. | Other: Health education<br>* Health education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline body composition at 4 months and 8 months | bioelectrical impedance analysis for body composition | baseline, 4 months, 8 months | 
| change from baseline body function (ADL)at 4 months and 8 months | The barthel index for activities of daily living | baseline, 4 months, 8 months | 
| change from baseline muscle strength at 4 months and 8 months | lb or kg | baseline, 4 months, 8 months | 
| 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. | baseline, 4 months, 8 months | 
| 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. | baseline, 4 months, 8 months | 
| change from baseline quality of life(dementia) at 4 months and 8 months | QUALIDEM is a dementia-specific quality of life instrument. | baseline, 4 months, 8 months | 
| change from baseline questionnaire of quality of life at 4 months and 8 months | PERSONAL WELLBEING INDEX for quality of life measurement. | baseline, 4 months, 8 months | 
| change from baseline body weight at 4 months and 8 months | kg | baseline, 4 months, 8 months | 
| change from baseline body height at 4 months and 8 months | cm | baseline, 4 months, 8 months | 
| change from baseline body function(IADL) at 4 months and 8 months | Instrumental Activities of Daily Living for body function | baseline, 4 months, 8 months | 
| change from baseline body function at 4 months and 8 months | Body Awareness Rating Scale for body function | baseline, 4 months, 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 4 months, 8 months | 
| 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. | baseline, 4 months, 8 months | 
| 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 | baseline, 4 months, 8 months | 
| change from baseline sleep(PSQI) at 4 months and 8 months | The pittsburgh sleep quality index for sleep time and efficiency. | baseline, 4 months, 8 months | 
| 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. | baseline, 4 months, 8 months | 
| change from baseline mental at 4 months and 8 months | Clock test for constructional measurement. | baseline, 4 months, 8 months | 
| change from baseline sleep at 4 months and 8 months | The actigraph for sleep time and efficiency. | baseline, 4 months, 8 months |