CClinicalTrials.gg
CompletedNCT06391983Updated Apr 30, 2024

The Impact of Moderate Resistance Training on IMAT in Elderly Diabetes Patients Without Obesity

An interventional study of resistance training (elastic band) in Type 2 Diabetes, sponsored by Lou Qingqing. Completed at 1 site in China. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Lou Qingqing · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jul 2021, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 85 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Lou Qingqing as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients who had severe chronic diabetes complications(e.g., stroke, myocardial infarction, end stage renal disease, proliferative retinopathy)
  • Cognitive impairments
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
85 participants (actual)

Study arms

  • 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.

    Other: resistance training (elastic band)

  • 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.

    Other: resistance training (elastic band)

Interventions

  • Otherresistance training (elastic band)

    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.

06

What researchers measure

Primary outcomes

  1. The primary outcome were the changes of IMAT

    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.

    Time frame: 6 months

07

Study locations

1 site
  • The First Affiliated Hospital of Hainan Medical University
    Haikou, Hainan 570102, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06391983
Lead sponsor
Lou Qingqing
Responsible party
Lou Qingqing (M.D. Director,Hainan Clinical Medical Research Center for Metabolic Disease, The First Affiliated Hospital of Hainan Medical University) — Sponsor-investigator
First posted
Apr 30, 2024
Start date
Jul 1, 2021
Primary completion
Feb 28, 2022
Completion
Feb 28, 2022
Last update
Apr 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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