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Home-based Resistance Training to Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04755660
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
Taiwan Nurses Association
Information provided by (Responsible Party):
Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Exercise behavior change for resistance exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: Single (Outcomes Assessor)
Masking Description: single
Primary Purpose: Treatment
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
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : November 12, 2021
Estimated Study Completion Date : November 12, 2021

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Muscle strength [ 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.

  2. Body composition [ Time Frame: Change from Baseline to 12 weeks ]
    In this study, body composition was measured by OMROM HBF-701 for body weight and body fat machine were used to measure the body weight, body fat, and limb skeletal muscle ratio of the participants. Using single frequency 4 poles (using 50 kHz single 1 frequency, measured by 4 guide poles-hands and feet), the skeletal muscle rate of the whole body, arms, trunk, and feet was measured, The value range is 5.0~50.0%, with 0.1% as the unit.

  3. 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.

  4. Physical Performance [ Time Frame: Change from Baseline to 12 weeks ]

    Physical performance was 30-s chair stand test,6-meter walking speed

    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

    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 s of the test.


  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04755660


Contacts
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Contact: Tsae -Jyy Wang, MD 886-2-28227101-3118 tsaejyy@ntunhs.edu.tw
Contact: Ting-Ru Lin, RN 886-2-8609-3884 r0004467@gmail.com

Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan
Contact: LI-MIN CHUANG, MSN    886-2-28332211 ext 5382    R002651@ms.skh.org.tw   
Sponsors and Collaborators
National Taipei University of Nursing and Health Sciences
Taiwan Nurses Association
Investigators
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Principal Investigator: Tsae -Jyy Wang, Professor National Taipei University of Nursing and Health Sciences
More Information
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Publications:

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Responsible Party: Tsae Jyy, Wang, Professor, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier: NCT04755660    
Other Study ID Numbers: 2020-11-004B
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences:
Diabetes Mellitus, Type 2
Resistance exercise
Muscle strength
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases