Clinical trial NCT04755660: Home-based Resistance Training to Patients With Type 2 Diabetes
Official title: Behavioral Intervention and Home-based Resistance Training to Increase Physical Activity and Muscle Strength in Patients With Type 2 Diabetes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Resistance exercise
Muscle strength
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Taiwan Nurses Association
First posted: 2021-02-16
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity
timeFrame: Change from Baseline to 12 weeks
Secondary outcomes:
measure: Hand Grip Strength(kg)
timeFrame: Change from Baseline to 12 weeks
measure: Body Composition
timeFrame: Change from Baseline to 12 weeks
measure: Self-efficacy
timeFrame: Change from Baseline to 12 weeks
measure: Physical Performance_30-s Chair Stand Test.
timeFrame: Change from Baseline to 12 weeks
measure: Hemoglobin A1c
timeFrame: Change from Baseline to 12 weeks
measure: Physical Performance _6-meter Walking Speed.
timeFrame: Change from Baseline to 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tsae -Jyy Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.