Influence of Sit Muscle Strength Training and Game on Elderly

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Aging; Elderly; Physical Disability
• Intervention / Treatment: Other: Sit muscle strength training; Other: Game training; Other: Sitting strength + game training; Other: 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 Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 406
    • Central Taiwan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Central Taiwan University of Science and Technology
• Investigators: Study Chair: Shu-Ching Chiu, Phd, Instructor of Central Taiwan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Actual): January 4, 2021
• Study Completion (Actual): January 4, 2021

Study Registration Dates

• First Submitted: December 9, 2017
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: CentralTaiwanUST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No