Skip to content

Home-based Resistance Training to Patients With Type 2 Diabetes

Behavioral Intervention and Home-based Resistance Training to Increase Physical Activity and Muscle Strength in Patients With Type 2 Diabetes: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04755660
Enrollment
90
Registered
2021-02-16
Start date
2021-03-15
Completion date
2021-12-30
Last updated
2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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

BEHAVIORALExercise 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.

Sponsors

Taiwan Nurses Association
CollaboratorOTHER
National Taipei University of Nursing and Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

single

Intervention model description

Randomized

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Physical ActivityChange 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.

Secondary

MeasureTime frameDescription
Body CompositionChange 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.
Self-efficacyChange 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.
Hand Grip Strength(kg)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.
Hemoglobin A1cChange 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.
Physical Performance _6-meter Walking Speed.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
Physical Performance_30-s Chair Stand Test.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.

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

ArmCount
Control Group
received care as usual
31
EBCG
Exercise behavior change group (EBCG)
29
EBRG
Elastic band resistance exercise group( EBRG)
30
Total90

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up110
Overall StudyPhysician Decision001
Overall StudyWithdrawal by Subject011

Baseline characteristics

CharacteristicControl GroupEBCGEBRGTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
20 Participants16 Participants12 Participants48 Participants
Age, Categorical
Between 18 and 65 years
11 Participants13 Participants18 Participants42 Participants
Age, Continuous67.61 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 Participants29 Participants30 Participants90 Participants
Region of Enrollment
Taiwan
31 participants29 participants30 participants90 participants
Sex: Female, Male
Female
15 Participants14 Participants18 Participants47 Participants
Sex: Female, Male
Male
16 Participants15 Participants12 Participants43 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 290 / 30
other
Total, other adverse events
0 / 310 / 290 / 30
serious
Total, serious adverse events
0 / 310 / 290 / 30

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Control GroupPhysical Activity59.98 score on a scaleStandard Deviation 52.94
EBCGPhysical Activity48.21 score on a scaleStandard Deviation 63.77
EBRGPhysical Activity59.43 score on a scaleStandard Deviation 46.1
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupBody Compositionskeletal muscle ratio25.02 percentage of body weightStandard Deviation 3.74
Control GroupBody Compositionbody fat ratio27.88 percentage of body weightStandard Deviation 7.25
EBCGBody Compositionskeletal muscle ratio23.87 percentage of body weightStandard Deviation 3.7
EBCGBody Compositionbody fat ratio27.09 percentage of body weightStandard Deviation 7.45
EBRGBody Compositionskeletal muscle ratio24.74 percentage of body weightStandard Deviation 3.51
EBRGBody Compositionbody fat ratio27.07 percentage of body weightStandard Deviation 7.06
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Control GroupHand Grip Strength(kg)28 KgStandard Deviation 7.93
EBCGHand Grip Strength(kg)29.36 KgStandard Deviation 10.03
EBRGHand Grip Strength(kg)28.22 KgStandard Deviation 7.61
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Control GroupHemoglobin A1c7.24 percentage of total haemoglobinStandard Deviation 1.03
EBCGHemoglobin A1c7.16 percentage of total haemoglobinStandard Deviation 0.89
EBRGHemoglobin A1c7.11 percentage of total haemoglobinStandard Deviation 0.85
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Control GroupPhysical Performance_30-s Chair Stand Test.12.35 chair standsStandard Deviation 3.96
EBCGPhysical Performance_30-s Chair Stand Test.13.76 chair standsStandard Deviation 3.91
EBRGPhysical Performance_30-s Chair Stand Test.13.97 chair standsStandard Deviation 4.13
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Control GroupPhysical Performance _6-meter Walking Speed.0.09 meter/secondStandard Deviation 0.18
EBCGPhysical Performance _6-meter Walking Speed.0.18 meter/secondStandard Deviation 0.64
EBRGPhysical Performance _6-meter Walking Speed.0.13 meter/secondStandard Deviation 0.22
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Control GroupSelf-efficacy2.53 score on a scaleStandard Deviation 2.96
EBCGSelf-efficacy4.0 score on a scaleStandard Deviation 2.49
EBRGSelf-efficacy3.72 score on a scaleStandard Deviation 2.68

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026