Influence of Sit Muscle Strength Training and Game on Elderly

June 30, 2022 updated by: Chiu Shu-Ching, Central Taiwan University of Science and Technology
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change from baseline body composition at 4 months and 8 months
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 8 months
lb or kg
baseline, 4 months, 8 months
change from baseline quality of life at 4 months and 8 months
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 8 months
kg
baseline, 4 months, 8 months
change from baseline body height at 4 months and 8 months
Time Frame: baseline, 4 months, 8 months
cm
baseline, 4 months, 8 months
change from baseline body function(IADL) at 4 months and 8 months
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 8 months
Body Awareness Rating Scale for body function
baseline, 4 months, 8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline cognition at 4 months and 8 months
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 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
Time Frame: baseline, 4 months, 8 months
Clock test for constructional measurement.
baseline, 4 months, 8 months
change from baseline sleep at 4 months and 8 months
Time Frame: baseline, 4 months, 8 months
The actigraph for sleep time and efficiency.
baseline, 4 months, 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Taiwan University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shu-Ching Chiu, Phd, Instructor of Central Taiwan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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