Influence of Sit Muscle Strength Training and Game on Elderly

Aging Clinical Trial

Official title:

Influence of Sit Muscle Strength Training and Game on Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411382
• Other study ID #: CentralTaiwanUST
• Status: Completed
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: January 4, 2021

Study information

• Verified date: June 2022
• Source: Central Taiwan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 4, 2021
• Est. primary completion date: January 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aging
• Dementia
• Elderly
• Physical Disability

Intervention

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.
• Game training
Game training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes.
• 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).
• Health education
Health education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe.

Locations

Country	Name	City	State
Taiwan	Central Taiwan University of Science and Technology	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Central Taiwan University of Science and Technology

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline body composition at 4 months and 8 months	bioelectrical impedance analysis for body composition	baseline, 4 months, 8 months
Primary	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
Primary	change from baseline muscle strength at 4 months and 8 months	lb or kg	baseline, 4 months, 8 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	change from baseline body weight at 4 months and 8 months	kg	baseline, 4 months, 8 months
Primary	change from baseline body height at 4 months and 8 months	cm	baseline, 4 months, 8 months
Primary	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
Primary	change from baseline body function at 4 months and 8 months	Body Awareness Rating Scale for body function	baseline, 4 months, 8 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	change from baseline mental at 4 months and 8 months	Clock test for constructional measurement.	baseline, 4 months, 8 months
Secondary	change from baseline sleep at 4 months and 8 months	The actigraph for sleep time and efficiency.	baseline, 4 months, 8 months