Influence of Sit Muscle Strength Training and Game on Elderly

Not Applicable

Completed

• Conditions: Aging; Dementia; Elderly; Physical Disability

• Registration Number: NCT03411382
• Lead Sponsor: Central Taiwan University of Science and Technology

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.

Study Timeline

• Study First Submitted: 2017-12-09
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-26
• Study Start: 2018-02-02
• Primary Completion: 2021-01-04
• Study Completion: 2021-01-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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).

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Central Taiwan University of Science and Technology; 🇨🇳 Taichung, Taiwan