Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2, Resistance exercise, Muscle strength
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.
Interventions
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.
Sponsors
Study design
Masking description
single
Intervention model description
Randomized
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 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
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | Change from Baseline to 12 weeks | 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. |
| Self-efficacy | 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. |
| Hand Grip Strength(kg) | 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. |
| Hemoglobin A1c | 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. |
| Physical Performance _6-meter Walking Speed. | Change from Baseline to 12 weeks | 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 |
| Physical Performance_30-s Chair Stand Test. | Change from Baseline to 12 weeks | 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. |
Countries
Taiwan
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Control Group received care as usual | 31 |
| EBCG Exercise behavior change group (EBCG) | 29 |
| EBRG Elastic band resistance exercise group( EBRG) | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Control Group | EBCG | EBRG | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 16 Participants | 12 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 13 Participants | 18 Participants | 42 Participants |
| Age, Continuous | 67.61 years STANDARD_DEVIATION 7.68 | 66.86 years STANDARD_DEVIATION 9.53 | 62.77 years STANDARD_DEVIATION 7.87 | 65.76 years STANDARD_DEVIATION 8.56 |
| Race/Ethnicity, Customized Chinese | 31 Participants | 29 Participants | 30 Participants | 90 Participants |
| Region of Enrollment Taiwan | 31 participants | 29 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 15 Participants | 14 Participants | 18 Participants | 47 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 12 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 | 0 / 30 |
Outcome results
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.
Time frame: Change from Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Physical Activity | 59.98 score on a scale | Standard Deviation 52.94 |
| EBCG | Physical Activity | 48.21 score on a scale | Standard Deviation 63.77 |
| EBRG | Physical Activity | 59.43 score on a scale | Standard Deviation 46.1 |
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.
Time frame: Change from Baseline to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Body Composition | skeletal muscle ratio | 25.02 percentage of body weight | Standard Deviation 3.74 |
| Control Group | Body Composition | body fat ratio | 27.88 percentage of body weight | Standard Deviation 7.25 |
| EBCG | Body Composition | skeletal muscle ratio | 23.87 percentage of body weight | Standard Deviation 3.7 |
| EBCG | Body Composition | body fat ratio | 27.09 percentage of body weight | Standard Deviation 7.45 |
| EBRG | Body Composition | skeletal muscle ratio | 24.74 percentage of body weight | Standard Deviation 3.51 |
| EBRG | Body Composition | body fat ratio | 27.07 percentage of body weight | Standard Deviation 7.06 |
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.
Time frame: Change from Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Hand Grip Strength(kg) | 28 Kg | Standard Deviation 7.93 |
| EBCG | Hand Grip Strength(kg) | 29.36 Kg | Standard Deviation 10.03 |
| EBRG | Hand Grip Strength(kg) | 28.22 Kg | Standard Deviation 7.61 |
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.
Time frame: Change from Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Hemoglobin A1c | 7.24 percentage of total haemoglobin | Standard Deviation 1.03 |
| EBCG | Hemoglobin A1c | 7.16 percentage of total haemoglobin | Standard Deviation 0.89 |
| EBRG | Hemoglobin A1c | 7.11 percentage of total haemoglobin | Standard Deviation 0.85 |
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.
Time frame: Change from Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Physical Performance_30-s Chair Stand Test. | 12.35 chair stands | Standard Deviation 3.96 |
| EBCG | Physical Performance_30-s Chair Stand Test. | 13.76 chair stands | Standard Deviation 3.91 |
| EBRG | Physical Performance_30-s Chair Stand Test. | 13.97 chair stands | Standard Deviation 4.13 |
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
Time frame: Change from Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Physical Performance _6-meter Walking Speed. | 0.09 meter/second | Standard Deviation 0.18 |
| EBCG | Physical Performance _6-meter Walking Speed. | 0.18 meter/second | Standard Deviation 0.64 |
| EBRG | Physical Performance _6-meter Walking Speed. | 0.13 meter/second | Standard Deviation 0.22 |
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.
Time frame: Change from Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Self-efficacy | 2.53 score on a scale | Standard Deviation 2.96 |
| EBCG | Self-efficacy | 4.0 score on a scale | Standard Deviation 2.49 |
| EBRG | Self-efficacy | 3.72 score on a scale | Standard Deviation 2.68 |