NCT03411382

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

February 2, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2021

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

2.9 years

First QC Date

December 9, 2017

Last Update Submit

June 30, 2022

Conditions

AgingPhysical DisabilityDementiaElderly

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (7)

  • change from baseline cognition at 4 months and 8 months

    baseline, 4 months, 8 months

  • change from baseline behavior at 4 months and 8 months

    baseline, 4 months, 8 months

  • change from baseline depression at 4 months and 8 months

    baseline, 4 months, 8 months

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

    baseline, 4 months, 8 months

  • change from baseline mental and cognition at 4 months and 8 months

    baseline, 4 months, 8 months

  • +2 more secondary outcomes

Study Arms (4)

Sit muscle strength training

EXPERIMENTAL

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

Game training

EXPERIMENTAL

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

Other: Game training

Sitting strength + game training

EXPERIMENTAL

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

Health education

PLACEBO COMPARATOR

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

Interventions

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.

Sit muscle strength training
Game trainingOTHER

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

Game training
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).

Sitting strength + game training
Health educationOTHER

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

Health education

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Taiwan University of Science and Technology

Taichung, 406, Taiwan

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Shu-Ching Chiu, Phd

    Instructor of Central Taiwan University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator of nursing department

Study Record Dates

First Submitted

December 9, 2017

First Posted

January 26, 2018

Study Start

February 2, 2018

Primary Completion

January 4, 2021

Study Completion

January 4, 2021

Last Updated

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)