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Completed

NCT Number: NCT03411382

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.

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Key information

Conditions

Aging Brain Diseases Central Nervous System Diseases Dementia Elderly Mental Disorders Nervous System Diseases Neurocognitive Disorders Physical Disability

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Taiwan University of Science and Technology

Taichung, 406, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

1.Inclusion Criteria:

  • Elderly persons between the age of 60 and 100 who take long-term care of the relevant units do not have limited sports
  • stable condition with sufficient physical strength: at least one hour sitting in the wheelchair or bed edge.
  • Subjects in the past month tended to live in static state (less than 150 minutes of exercise time per week).

2.Exclusion Criteria:

  • 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).
  • Unstable weight over the past six months (> ± 4 kg).

Treatment and study plan

Sit muscle strength training

Other

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

Other

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

Sitting strength + game training

Other

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

Other

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

Primary outcomes

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

    Time frame: baseline, 4 months, 8 months

    bioelectrical impedance analysis for body composition

  2. 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

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

    Time frame: baseline, 4 months, 8 months

    lb or kg

  4. 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.

  5. 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.

  6. 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.

  7. 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.

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

    Time frame: baseline, 4 months, 8 months

    kg

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

    Time frame: baseline, 4 months, 8 months

    cm

  10. 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

  11. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

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

    Time frame: baseline, 4 months, 8 months

    Clock test for constructional measurement.

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

    Time frame: baseline, 4 months, 8 months

    The actigraph for sleep time and efficiency.

Sponsors and collaborators

Lead sponsor

Central Taiwan University of Science and Technology

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2018
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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