Diabetes Mellitus, Type 2NCT04755660
Home-based Resistance Training to Patients With Type 2 Diabetes
A study testing Exercise behavior change for resistance exercise in people with Diabetes Mellitus, Type 2, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Exercise behavior change for resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes type 2
- age >50 years old
- sedentary lifestyle (PASE questionnaire leisure time physical activities score female <30 points, male <40 points)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Exercise behavior change for resistance exercise
- Keywords
- Diabetes Mellitus, Type 2, Resistance exercise, Muscle strength
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise behavior change for resistance exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise behavior change group (EBCG) | Experimental | Behavior Change Theory-based intervention + Resistance Exercise Receives: Behavioral: Exercise behavior change for resistance exercise |
| Elastic band resistance exercise group( EBRG) | Active comparator | Elastic Band Resistance Exercise Receives: Behavioral: Exercise behavior change for resistance exercise |
| Usual care (UC) | Sham comparator | usual care: exercise education Receives: Behavioral: Exercise behavior change for resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
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.
Measured: Change from Baseline to 12 weeks
Secondary outcomes (6)
Hand Grip Strength(kg)
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.
Measured: Change from Baseline to 12 weeks
Body Composition
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.
Measured: Change from Baseline to 12 weeks
Self-efficacy
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.
Measured: Change from Baseline to 12 weeks
Physical Performance_30-s Chair Stand Test.
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.
Measured: Change from Baseline to 12 weeks
Hemoglobin A1c
Glycosylated Hemoglobin was taken some days(around 1 week) before the clinical visit. HbA1c was measured by a commercial pathology laboratory using standard assays.
Measured: Change from Baseline to 12 weeks
Physical Performance _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
Measured: Change from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start15 Mar 2021
- Primary completion7 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Nurses Association
- Responsible party
- Principal investigator, Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences
- Investigators
- Tsae -Jyy Wang, Professor, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755660
- Sponsor's protocol ID
- 2020-11-004B
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2021
- Last updated
- 18 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31275784Nomura 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.
PubMed 30697507Lee 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.
PubMed 28382531Mogre 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.
PubMed 30791160Kim 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.
PubMed 26017097
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04755660
- Acronym / sponsor ID
- 2020-11-004B
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Resistance exercise, Muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Taiwan Nurses Association
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Posted 18 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Exercise behavior change group (EBCG) | Experimental | Behavioral: Exercise behavior change for resistance exerciseBehavior Change Theory-based intervention + Resistance Exercise |
| Elastic band resistance exercise group( EBRG) | Active comparator | Behavioral: Exercise behavior change for resistance exerciseElastic Band Resistance Exercise |
| Usual care (UC) | Sham comparator | Behavioral: Exercise behavior change for resistance exerciseusual care: exercise education |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetes type 2
- age >50 years old
- sedentary lifestyle (PASE questionnaire leisure time physical activities score female <30 points, male <40 points)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise behavior change for resistance exerciseThe 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. | Behavioural | Elastic band resistance exercise group( EBRG), Exercise behavior change group (EBCG), Usual care (UC) |
Primary outcome
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.
6 secondary outcomes
Hand Grip Strength(kg)
Time frame: Change from Baseline to 12 weeks
Body Composition
Time frame: Change from Baseline to 12 weeks
Self-efficacy
Time frame: Change from Baseline to 12 weeks
Physical Performance_30-s Chair Stand Test.
Time frame: Change from Baseline to 12 weeks
Hemoglobin A1c
Time frame: Change from Baseline to 12 weeks
Physical Performance _6-meter Walking Speed.
Time frame: Change from Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31275784Mori 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.
- Background: PubMed 30697507Nomura 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.
- Background: PubMed 28382531Lee 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.
- Background: PubMed 30791160Mogre 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.
- Background: PubMed 26017097Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsae -Jyy Wang, Professor principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise behavior change for resistance exercise in people with Diabetes Mellitus, Type 2, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: Change from Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755660, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.