Home-based Resistance Training to Patients With Type 2 Diabetes

January 30, 2025 updated by: Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences

Behavioral Intervention and Home-based Resistance Training to Increase Physical Activity and Muscle Strength in Patients With Type 2 Diabetes: A Randomized Clinical Trial

The purpose of this study is to compare motivational interviews and self-efficacy theory-based exercise behavior and home-based resistance exercise (elastic band to non-elastic band) to improve physical activity, muscle strength, body composition, and self-efficacy of exercise in type 2 diabetic patients. The effectiveness of performance and exercise compliance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study adopts an experimental research design. A total of 90 cases of type 2 diabetes who are not exercising regularly are recruited from the outpatient clinic of the Metabolism Department of a medical center in the north to participate in the study. Blocks 6, and 12 (Block) are randomly assigned. The research subjects were assigned to the behavior change and resistance exercise group, and home-based resistance exercise( with elastic band), and the control group. The behavior changes and resistance exercise group received motivational interviews and self-efficacy theory-based exercise behavior changes and resistance exercise guidance intervention, home resistance exercise. the group received home elastic band resistance exercise training, and the control group received regular exercise guidance. The three groups received data collection of physical activity, muscle strength, body composition, physical activity function, and exercise self-efficacy in the pre-test, the sixth week, and the twelfth week. During the study period, the exercise log was used to collect the mediating variable about exercise compliance (Time × frequency) data collection. This study compares the effectiveness of motivational interviews and self-efficacy theory-based exercise behavior intervention and home resistance exercise training programs. The result will show an empirical evidence for type 2 diabetic patients to increase physical activity and muscle strength in the future, and will also apply to training of muscle strengthening in diabetes and other chronic disease.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • 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
      • Taipei, Taiwan
        • Shin Kong Wu Ho-Su Memorial Hospital

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diabetes type 2
  • age >50 years old
  • sedentary lifestyle (PASE questionnaire leisure time physical activities score female <30 points, male <40 points)

Exclusion Criteria:

  • severe congestive heart failure (New York Heart Association Functional Class III and IV)
  • severe renal failure (estimated Glomerular Filtration Rate < 15 mL/min/1.73m2)
  • stroke ((The National Institutes of Health Stroke Scale > 15)
  • Peripheral Arterial Occlusive Disease
  • Foot ulcer over 6 month
  • Severe muscle diseases and rheumatoid arthritis
  • Cognitive or mental disorders who cannot understand and cooperate with the exercise plan
  • those who are accessed by the doctor to be avoided for exercise

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise behavior change group (EBCG)
Behavior Change Theory-based intervention + Resistance Exercise
Behavioral: Exercise behavior change for resistance exercise
The intervention includes motivational interviews and self-efficacy theory-based exercise behavior and home-based resistance exercise intervention (by Elastic Band or non- Elastic Band ), and 3 follow-up telephone calls. The usual care group will receive exercise counseling.
Active Comparator: Elastic band resistance exercise group( EBRG)
Elastic Band Resistance Exercise
Behavioral: Exercise behavior change for resistance exercise
The intervention includes motivational interviews and self-efficacy theory-based exercise behavior and home-based resistance exercise intervention (by Elastic Band or non- Elastic Band ), and 3 follow-up telephone calls. The usual care group will receive exercise counseling.
Sham Comparator: Usual care (UC)
usual care: exercise education
Behavioral: Exercise behavior change for resistance exercise
The intervention includes motivational interviews and self-efficacy theory-based exercise behavior and home-based resistance exercise intervention (by Elastic Band or non- Elastic Band ), and 3 follow-up telephone calls. The usual care group will receive exercise counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: Change from Baseline to 12 weeks
Physical activity measured leisure-time physical activity for 7 days by Physical Activity Scale for the Elderly (PASE).PASE was self-administered occupational, household, and leisure physical activities. Participants were asked about the intensity, frequency, and duration of a variety of activities, including walking; strenuous, moderate, and light sports; muscle strength and endurance; occupational activities that included standing or walking; lawn work and gardening; caring for another person; home repairs; and heavy and light housework over the previous 7 days. The frequency and duration of each activity were multiplied by an empirically derived item weight and summed to compute the total PASE score activity.15 The PASE questions work-related, household, and leisure time activities for the 7 days preceding the interview. The score is continuous, ranges from 0 to 793, and higher values indicate a more active individual.
Change from Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy
Time Frame: Change from Baseline to 12 weeks
self-efficacy about exercise will measured by Chinese version of the self-efficacy for exercise (SEE-C) scale . It was designed to test people's confidence to continue exercising in the face of barriers to exercise.The participants will instruct to listen to the statement and then choose an option from 0 (not confident) to 10 (very confident). The scale was scored by summing the numerical ratings for each response and dividing the total by the number of non-missing responses. The mean scores for the self-efficacy of exercise ranged from 0 to 10, with the higher scores representing greater exercise self-efficacy.SEE-C has acceptable levels of reliability and validity for the scale when used with older people in Taiwan.
Change from Baseline to 12 weeks
Hemoglobin A1c
Time Frame: Change from Baseline to 12 weeks
Glycosylated Hemoglobin was taken some days(around 1 week) before the clinical visit. HbA1c was measured by a commercial pathology laboratory using standard assays.
Change from Baseline to 12 weeks
Hand Grip Strength(kg)
Time Frame: Change from Baseline to 12 weeks
Hand Grip strength bilateral Grip strength will be measured using a Jamar dynamometer by asking the patient to squeeze the dynamometer handle with each hand third alternately, starting with the right hand using a standardized protocol. A brief break of approximately 1 min will be allowed between each measurement, and the maximum value will be recorded in kilograms (kg). The relative test-retest reliability of grip-strength measures obtained by dynamometry was good to excellent (intra-class correlation coefficients > 0.80) (Bohannon,2017).ICC of the test-retest with one single operator ranged from 0·60 (0·37-0·83) for the ankle extensors to 0·85 (0·74-0·95) for the elbow flexors.
Change from Baseline to 12 weeks
Body Composition
Time Frame: Change from Baseline to 12 weeks
In this study, body composition used bioelectrical impedance analysis (BIA) to analyze body muscle and fat data.was measured by OM-ROM HF-701 for body weight, and a body fat machine was used to measure the participants' body weight, body fat, and limb skeletal muscle ratio. The skeletal muscle rate of the whole body, arms, trunk, and feet was measured using a single frequency on four poles (a 50 kHz single frequency, measured by four guide hands and feet). The value range is 5.0~50.0%, with 0.1% as the unit. The measurements obtained from the device indicate the ratio of total skeletal muscle mass and body fat relative to body weight. The skeletal muscle weight cut-off points for sarcopenia are <37.5% for men and <32.6% for women; the cut-off points for fat rate and obesity are >29% for men and >40% for women.
Change from Baseline to 12 weeks
Physical Performance_30-s Chair Stand Test.
Time Frame: Change from Baseline to 12 weeks

Physical performance was a 30-s chair stand test.

30-s chair stand test: Participants were instructed to rise as quickly as possible from a seated position, with full body weight on the chair, to a standing posture, with their legs fully extended while keeping their arms folded across their chest. The 30CST measures the maximal number of chair stands completed during 30 seconds of the test.
Change from Baseline to 12 weeks
Physical Performance _6-meter Walking Speed.
Time Frame: Change from Baseline to 12 weeks
6-meter walking speed: Participants walked twice at their usual pace over a 6-meter course. Time in seconds was recorded between the 2nd and the 4th meter. Distance (m) divided by time (s) was used to calculate walking speed. Slow gait speed was defined using AWGS 2019 reference value of < 1.0 m/s
Change from Baseline to 12 weeks

Collaborators and Investigators

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

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Taiwan Nurses Association

Investigators

  • Principal Investigator: Tsae -Jyy Wang, Professor, National Taipei University of Nursing and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 15, 2021

Primary Completion (Actual)

December 7, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

January 31, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-11-004B

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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