Home-based Resistance Training to Patients With Type 2 Diabetes

NCT ID: NCT04755660

Last Updated: 2025-02-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
single

Study Groups

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Exercise behavior change group (EBCG)

Behavior Change Theory-based intervention + Resistance Exercise

Group Type EXPERIMENTAL

Exercise behavior change for resistance exercise

Intervention Type BEHAVIORAL

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.

Elastic band resistance exercise group( EBRG)

Elastic Band Resistance Exercise

Group Type ACTIVE_COMPARATOR

Exercise behavior change for resistance exercise

Intervention Type BEHAVIORAL

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.

Usual care (UC)

usual care: exercise education

Group Type SHAM_COMPARATOR

Exercise behavior change for resistance exercise

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taiwan Nurses Association

OTHER

Sponsor Role collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tsae Jyy, Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tsae -Jyy Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Mori H, Kuroda A, Matsuhisa M. Clinical impact of sarcopenia and dynapenia on diabetes. Diabetol Int. 2019 Jun 19;10(3):183-187. doi: 10.1007/s13340-019-00400-1. eCollection 2019 Jul.

Reference Type BACKGROUND
PMID: 31275784 (View on PubMed)

Nomura T, Kawae T, Kataoka H, Ikeda Y. Aging, physical activity, and diabetic complications related to loss of muscle strength in patients with type 2 diabetes. Phys Ther Res. 2018 Nov 30;21(2):33-38. doi: 10.1298/ptr.R0002. eCollection 2018.

Reference Type BACKGROUND
PMID: 30697507 (View on PubMed)

Lee J, Kim D, Kim C. Resistance Training for Glycemic Control, Muscular Strength, and Lean Body Mass in Old Type 2 Diabetic Patients: A Meta-Analysis. Diabetes Ther. 2017 Jun;8(3):459-473. doi: 10.1007/s13300-017-0258-3. Epub 2017 Apr 5.

Reference Type BACKGROUND
PMID: 28382531 (View on PubMed)

Mogre V, Johnson NA, Tzelepis F, Paul C. Barriers to diabetic self-care: A qualitative study of patients' and healthcare providers' perspectives. J Clin Nurs. 2019 Jun;28(11-12):2296-2308. doi: 10.1111/jocn.14835. Epub 2019 Mar 6.

Reference Type BACKGROUND
PMID: 30791160 (View on PubMed)

Kim YH, Kim KI, Paik NJ, Kim KW, Jang HC, Lim JY. Muscle strength: A better index of low physical performance than muscle mass in older adults. Geriatr Gerontol Int. 2016 May;16(5):577-85. doi: 10.1111/ggi.12514. Epub 2015 May 28.

Reference Type BACKGROUND
PMID: 26017097 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-11-004B

Identifier Type: -

Identifier Source: org_study_id

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