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AgingNCT03411382

Influence of Sit Muscle Strength Training and Game on Elderly

A study testing Sit muscle strength training, Game training and Sitting strength + game training in people with Aging and Physical Disability, run by Central Taiwan University of Science and Technology at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 100 years
Conditions the study is for
Aging, Physical Disability, Dementia
What is being tested?
Sit muscle strength training, Game training and Sitting strength + game training
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
207 participants
Where
1 siteTaiwan
Study dates
2 Feb 2018to 4 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Central Taiwan University of Science and Technology

    Taichung, 406

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
Sit muscle strength training, Game training, Sitting strength + game training, Health education
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sit muscle strength trainingOther

    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 trainingOther

    Game training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes.

  • Sitting strength + game trainingOther

    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 educationOther

    Health education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe.

Study groups in NCT03411382
Study groupRoleWhat they receive
Sit muscle strength trainingExperimentalSit 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.
Receives: Other: Sit muscle strength training
Game trainingExperimentalGame training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes.
Receives: Other: Game training
Sitting strength + game trainingExperimentalSitting strength training (using sandbag training conducted twice a week) and game training (such as ball activities and clay courses) conducted twice a week).
Receives: Other: Sitting strength + game training
Health educationPlacebo comparatorHealth education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe.
Receives: Other: Health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change from baseline body composition at 4 months and 8 months

    bioelectrical impedance analysis for body composition

    Measured: baseline, 4 months, 8 months

  2. change from baseline body function (ADL)at 4 months and 8 months

    The barthel index for activities of daily living

    Measured: baseline, 4 months, 8 months

  3. change from baseline muscle strength at 4 months and 8 months

    lb or kg

    Measured: baseline, 4 months, 8 months

  4. 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.

    Measured: baseline, 4 months, 8 months

  5. 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.

    Measured: baseline, 4 months, 8 months

  6. change from baseline quality of life(dementia) at 4 months and 8 months

    QUALIDEM is a dementia-specific quality of life instrument.

    Measured: baseline, 4 months, 8 months

  7. change from baseline questionnaire of quality of life at 4 months and 8 months

    PERSONAL WELLBEING INDEX for quality of life measurement.

    Measured: baseline, 4 months, 8 months

  8. change from baseline body weight at 4 months and 8 months

    kg

    Measured: baseline, 4 months, 8 months

  9. change from baseline body height at 4 months and 8 months

    cm

    Measured: baseline, 4 months, 8 months

  10. change from baseline body function(IADL) at 4 months and 8 months

    Instrumental Activities of Daily Living for body function

    Measured: baseline, 4 months, 8 months

  11. change from baseline body function at 4 months and 8 months

    Body Awareness Rating Scale for body function

    Measured: baseline, 4 months, 8 months

Secondary outcomes (7)

  1. 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.

    Measured: baseline, 4 months, 8 months

  2. 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.

    Measured: baseline, 4 months, 8 months

  3. 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

    Measured: baseline, 4 months, 8 months

  4. change from baseline sleep(PSQI) at 4 months and 8 months

    The pittsburgh sleep quality index for sleep time and efficiency.

    Measured: baseline, 4 months, 8 months

  5. 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.

    Measured: baseline, 4 months, 8 months

  6. change from baseline mental at 4 months and 8 months

    Clock test for constructional measurement.

    Measured: baseline, 4 months, 8 months

  7. change from baseline sleep at 4 months and 8 months

    The actigraph for sleep time and efficiency.

    Measured: baseline, 4 months, 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start2 Feb 2018
  3. Primary completion4 Jan 2021
  4. Study completion4 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03411382
Sponsor's protocol ID
CentralTaiwanUST
Status last verified
Jun 2022
First submitted
9 Dec 2017
Last updated
5 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sit muscle strength training, Game training and Sitting strength + game training in people with Aging and Physical Disability, run by Central Taiwan University of Science and Technology at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change from baseline body composition at 4 months and 8 months (time frame: baseline, 4 months, 8 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03411382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.

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