Trial Outcomes & Findings for Home-based Resistance Training to Patients With Type 2 Diabetes (NCT NCT04755660)
NCT ID: NCT04755660
Last Updated: 2025-02-18
Results Overview
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.
COMPLETED
NA
90 participants
Change from Baseline to 12 weeks
2025-02-18
Participant Flow
Cases were recruited at a medical center's metabolism, internal medicine outpatient clinics, and regional general clinics in Taiwan. The study received 254 referral cases, of which 9 were excluded because they did not meet the included conditions. From January 23 to December 10, 2019
Participant milestones
| Measure |
EBCG
Exercise behavior change group (EBCG): Study subjects received one-on-one motivational interviewing-based exercise coaching and home resistance exercise training. Research subjects can choose dumbbells, kettlebells, body weights, or fitness equipment according to individual preferences, and perform resistance exercises at least 3 days a week. The total resistance exercise time every day reaches 30 minutes, including the warm-up period, exercise period, and stretching period. Starting with an intensity of 50%-60% 1RM.
|
Control Group
The diabetes health teacher will provide written information and an oral explanation of diabetes exercise for about 15 minutes.
|
EBRG
Elastic band resistance exercise group( EBRG): The patient receives one-to-one individual guidance on the essentials of elastic band exercise in the outpatient clinic, and the patient is asked to teach back until the patient can safely and correctly use the elastic band to perform various movements. The interventional practitioner evaluates the patient's muscle strength and provides a Thera-Band® elastic band with appropriate resistance based on the individual differences of the case. Starting with a resistance that the patient can repeat 10-12 times before feeling fatigued, the home-based elastic band resistance exercise is performed three times a week. , at least 30 minutes each time.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
30
|
|
Overall Study
COMPLETED
|
28
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
EBCG
Exercise behavior change group (EBCG): Study subjects received one-on-one motivational interviewing-based exercise coaching and home resistance exercise training. Research subjects can choose dumbbells, kettlebells, body weights, or fitness equipment according to individual preferences, and perform resistance exercises at least 3 days a week. The total resistance exercise time every day reaches 30 minutes, including the warm-up period, exercise period, and stretching period. Starting with an intensity of 50%-60% 1RM.
|
Control Group
The diabetes health teacher will provide written information and an oral explanation of diabetes exercise for about 15 minutes.
|
EBRG
Elastic band resistance exercise group( EBRG): The patient receives one-to-one individual guidance on the essentials of elastic band exercise in the outpatient clinic, and the patient is asked to teach back until the patient can safely and correctly use the elastic band to perform various movements. The interventional practitioner evaluates the patient's muscle strength and provides a Thera-Band® elastic band with appropriate resistance based on the individual differences of the case. Starting with a resistance that the patient can repeat 10-12 times before feeling fatigued, the home-based elastic band resistance exercise is performed three times a week. , at least 30 minutes each time.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Home-based Resistance Training to Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Control Group
n=31 Participants
received care as usual
|
EBCG
n=29 Participants
Exercise behavior change group (EBCG)
|
EBRG
n=30 Participants
Elastic band resistance exercise group( EBRG)
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Age, Continuous
|
67.61 years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
66.86 years
STANDARD_DEVIATION 9.53 • n=7 Participants
|
62.77 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
65.76 years
STANDARD_DEVIATION 8.56 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
30 participants
n=5 Participants
|
90 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 12 weeksPhysical 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.
Outcome measures
| Measure |
Control Group
n=31 Participants
received care as usual
|
EBCG
n=29 Participants
Exercise behavior change group (EBCG)
|
EBRG
n=30 Participants
Elastic band resistance exercise group( EBRG)
|
|---|---|---|---|
|
Physical Activity
|
59.98 score on a scale
Standard Deviation 52.94
|
48.21 score on a scale
Standard Deviation 63.77
|
59.43 score on a scale
Standard Deviation 46.10
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksHand 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.
Outcome measures
| Measure |
Control Group
n=31 Participants
received care as usual
|
EBCG
n=30 Participants
Exercise behavior change group (EBCG)
|
EBRG
n=29 Participants
Elastic band resistance exercise group( EBRG)
|
|---|---|---|---|
|
Hand Grip Strength(kg)
|
28 Kg
Standard Deviation 7.93
|
29.36 Kg
Standard Deviation 10.03
|
28.22 Kg
Standard Deviation 7.61
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksIn 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.
Outcome measures
| Measure |
Control Group
n=31 Participants
received care as usual
|
EBCG
n=29 Participants
Exercise behavior change group (EBCG)
|
EBRG
n=30 Participants
Elastic band resistance exercise group( EBRG)
|
|---|---|---|---|
|
Body Composition
skeletal muscle ratio
|
25.02 percentage of body weight
Standard Deviation 3.74
|
23.87 percentage of body weight
Standard Deviation 3.7
|
24.74 percentage of body weight
Standard Deviation 3.51
|
|
Body Composition
body fat ratio
|
27.88 percentage of body weight
Standard Deviation 7.25
|
27.09 percentage of body weight
Standard Deviation 7.45
|
27.07 percentage of body weight
Standard Deviation 7.06
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksself-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.
Outcome measures
| Measure |
Control Group
n=31 Participants
received care as usual
|
EBCG
n=29 Participants
Exercise behavior change group (EBCG)
|
EBRG
n=30 Participants
Elastic band resistance exercise group( EBRG)
|
|---|---|---|---|
|
Self-efficacy
|
2.53 score on a scale
Standard Deviation 2.96
|
4.0 score on a scale
Standard Deviation 2.49
|
3.72 score on a scale
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPhysical 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.
Outcome measures
| Measure |
Control Group
n=31 Participants
received care as usual
|
EBCG
n=29 Participants
Exercise behavior change group (EBCG)
|
EBRG
n=30 Participants
Elastic band resistance exercise group( EBRG)
|
|---|---|---|---|
|
Physical Performance_30-s Chair Stand Test.
|
12.35 chair stands
Standard Deviation 3.96
|
13.76 chair stands
Standard Deviation 3.91
|
13.97 chair stands
Standard Deviation 4.13
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksGlycosylated Hemoglobin was taken some days(around 1 week) before the clinical visit. HbA1c was measured by a commercial pathology laboratory using standard assays.
Outcome measures
| Measure |
Control Group
n=31 Participants
received care as usual
|
EBCG
n=29 Participants
Exercise behavior change group (EBCG)
|
EBRG
n=30 Participants
Elastic band resistance exercise group( EBRG)
|
|---|---|---|---|
|
Hemoglobin A1c
|
7.24 percentage of total haemoglobin
Standard Deviation 1.03
|
7.16 percentage of total haemoglobin
Standard Deviation 0.89
|
7.11 percentage of total haemoglobin
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeks6-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
Outcome measures
| Measure |
Control Group
n=29 Participants
received care as usual
|
EBCG
n=30 Participants
Exercise behavior change group (EBCG)
|
EBRG
n=31 Participants
Elastic band resistance exercise group( EBRG)
|
|---|---|---|---|
|
Physical Performance _6-meter Walking Speed.
|
0.09 meter/second
Standard Deviation 0.18
|
0.18 meter/second
Standard Deviation 0.64
|
0.13 meter/second
Standard Deviation 0.22
|
Adverse Events
Control Group
EBCG
EBRG
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Tingru Lin
National Taipei University of Nursing and Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place