Home-based Resistance Training to Patients With Type 2 Diabetes

National Taipei University of Nursing and Health Sciences

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Exercise behavior change for resistance exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04755660

2020-11-004B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Exercise behavior change group (EBCG)

Experimental group

Description:

Behavior Change Theory-based intervention + Resistance Exercise

Treatment:

Behavioral: Exercise behavior change for resistance exercise

Elastic band resistance exercise group( EBRG)

Active Comparator group

Description:

Elastic Band Resistance Exercise

Treatment:

Behavioral: Exercise behavior change for resistance exercise

Usual care (UC)

Sham Comparator group

Description:

usual care: exercise education

Treatment:

Behavioral: Exercise behavior change for resistance exercise