- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06391983
The Impact of Moderate Resistance Training on IMAT in Elderly Diabetes Patients Without Obesity
Effect of Resistance Training on Intermuscular Adipose Tissue in Patients With Type 2 Diabetes
Data shows that high intensity resistance training reduces Intermuscular Adipose Tissue (IMAT) in obesity adults. Whether moderate resistance training reduces IMAT for non-obese elderly patients with diabetes is not clear. Therefore, this study aimed to evaluate the impact of moderate resistance training on IMAT in elderly patients with type 2 diabetes, and the independent effect of IMAT reduction on metabolic outcomes.
In this randomized control trial (RCT), 85 type 2 diabetes patients were randomized into the resistance training group (42 participants) and control group (43 participants) for 6-month intervention. The control group was not asked to participate in any regular exercise. However, the group attended online group educational sessions about diabetes self management once a month, and were asked to record their daily physical activities. Online mini program Wechat was used for communication. The intervention group attended online group education sessions on diabetes self management as the control group, as well as resistance exercise training sessions three times weekly; the sessions were approximately 40 minutes long and included 5 minutes of warm up, followed by 30 minutes of resistance exercises and 5 minutes of cool down. The resistance training consisted of ten upper-body and lower-body exercises using elastic band. The initial sessions were 1 to 2 sets of 6 to 8 repetitions at 45% of the one-repetition maximum (1 RM). It was increased progressively to 2 to 3 sets of 8 to 12 repetitions at approximately 50% -55% of 1 RM. The primary outcome were the changes of IMAT measured by computed tomography(CT)scan and magnetic resonance imaging (MRI) interactive decomposition of water and fat with echo asymmetry and least squares qualification sequence (IDEAL-IQ). The secondary outcomes were the changes in metabolic parameters.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hainan
-
Haikou, Hainan, China, 570102
- The First Affiliated Hospital of Hainan Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Type 2 diabetes
- ≥60 and <75 years of age
- Normal muscle strength
- Body-mass index (BMI) ≤35
- Glycosylated hemoglobin A1c (HbA1c) < 9%
Exclusion Criteria:
- Patients who had severe chronic diabetes complications(e.g., stroke, myocardial infarction, end stage renal disease, proliferative retinopathy)
- Cognitive impairments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: resistance training
The intervention group attended online group education sessions on diabetes self management, as well as resistance exercise training sessions three times weekly; the sessions were approximately 40 minutes long and included 5 minutes of warm up, followed by 30 minutes of resistance exercises and 5 minutes of cool down.
The resistance training consisted of ten upper-body and lower-body exercises using elastic band.
The initial sessions were 1 to 2 sets of 6 to 8 repetitions at 45% of the one-repetition maximum (1 RM).
It was increased progressively to 2 to 3 sets of 8 to 12 repetitions at approximately 55% of 1 RM.
The 10 resistance exercises were reported elsewhere.
Due to the Covid-19 pandemic, the participants performed resistance exercise at home, and 10 specific teaching videos (one video for each exercise) were provided for participants in this group.
Wechat was used for attendance taking and communication.
|
The intervention group attended online group education sessions on diabetes self management, as well as resistance exercise training sessions three times weekly; the sessions were approximately 40 minutes long and included 5 minutes of warm up, followed by 30 minutes of resistance exercises and 5 minutes of cool down.
The resistance training consisted of ten upper-body and lower-body exercises using elastic band.
The initial sessions were 1 to 2 sets of 6 to 8 repetitions at 45% of the one-repetition maximum (1 RM).
It was increased progressively to 2 to 3 sets of 8 to 12 approximately 50% -55% of 1 RM.
|
|
Experimental: Control Group
The control group was not asked to participate in any regular exercise.
However, the group attended online group educational sessions about diabetes self management once a month, and were asked to record their daily physical activities.
Online mini program Wechat was used for communication.
|
The intervention group attended online group education sessions on diabetes self management, as well as resistance exercise training sessions three times weekly; the sessions were approximately 40 minutes long and included 5 minutes of warm up, followed by 30 minutes of resistance exercises and 5 minutes of cool down.
The resistance training consisted of ten upper-body and lower-body exercises using elastic band.
The initial sessions were 1 to 2 sets of 6 to 8 repetitions at 45% of the one-repetition maximum (1 RM).
It was increased progressively to 2 to 3 sets of 8 to 12 approximately 50% -55% of 1 RM.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The primary outcome were the changes of IMAT
Time Frame: 6 months
|
MRI IDEAL-IQ was used to quantitatively assess IMAT in the middle of left thigh. This study used fat fraction as the indicator to quantify IMAT of the thigh muscle. CT scan was used to assess IMAT area. Hounsfeild (Hu) was used to quantify the density of muscle or fat. The density of IMAT area is low, between -190Hu to -30Hu. With regard to muscle area, there are two different density areas: Normal attenuation muscle area, with density between 31Hu to 100Hu, representing normal muscle area, and Low attenuation muscle area, with density between 0Hu to 30Hu, representing fat infiltration, the lower the Hu, the higher the fat infiltration. |
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LouQingqing
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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