Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia

May 19, 2025 updated by: Trinh Ngoc Anh, National Geriatric Hospital

Evaluating Resistance Training for Sarcopenia in Older Patients With Type 2 Diabetes: Treatment Outcomes

A randomized controlled clinical trial that will test how progressive resistance training will impact outcomes of sarcopenia in older patients with type 2 diabetes who have been diagnosed as sarcopenia. The intervention will be 12 weeks in duration with approximately 24 sessions of resistance exercises. Outcome measures will be collected at baseline, 4, 8 weeks and 12 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sarcopenia, prevalent among geriatric populations, involves the progressive loss of muscle mass and decline in muscular function. This age-related condition is associated with higher susceptibility to falls, comorbidities, and mortality. Resistance training emerges as a non-pharmacological intervention proven to alleviate and potentially delay the progression of sarcopenia. However, there are still few studies investigating its effects on outcomes in older patients with diabetes mellitus.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 100000
        • Recruiting
        • National Geriatric Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria
  • HbA1c ≥ 7.0 and ≤ 8.5%
  • Sarcopenia diagnosed using criteria from the Asian Working Group for Sarcopenia 2019
  • Age ≥ 60 and ≤ 80

Exclusion Criteria:

  • Acute diabetic complications
  • Patients are in the acute phase of musculoskeletal disorders: acute gout, progressing low-grade arthritis, acute joint pain due to joint degeneration, sciatic pain, and infectious arthritis.
  • Patients suffer from conditions significantly affecting cognition and mobility: sequelae of stroke (with weakness, limb paralysis), muscular weakness, limb disabilities, severe heart failure, severe cognitive decline, and psychiatric disorders.
  • Patients have been bedridden due to illness for more than 1 month within the past 3 months up to the recruitment time.
  • Patients with cardiovascular diseases: chest pain, uncontrolled blood pressure ≥160/100 mmHg, untreated cardiac arrhythmia, a history of congestive heart failure, severe valvular heart disease, myocarditis or pericarditis, and hypertrophic cardiomyopathy.
  • Renal failure with estimated glomerular function rate (Modification of Diet in Renal Disease equation) < 60 ml/min/m3 or serum creatinine ≥ 130 µmol/l
  • On treatment with Sodium-glucose cotransporter 2 inhibitors (SGLT2i)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

The intervention group receives supervised resistance training instructions and baseline treatment for sarcopenia and diabetes:

  • Resistance training with elastic bands aims to increase muscle strength and muscle mass of the upper and lower limbs. Training duration 12 weeks, frequency 2 times/week, intensity gradually increases.
  • Baseline treatment for diabetes and sarcopenia: Recommendations according to American Diabetes Association guidelines which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients and baseline treatment for sarcopenia (education about sarcopenia and treatment measures such as diet and exercise) and provide basic information on resistance training.
Behavioral: Progressive Resistance Training

Progressive resistance training includes face-to-face education on resistance training:

Resistance exercises with elastic bands include 9 exercises for 1 course. During the first 4 weeks, the patient exercises twice a week with a level of exertion according to Borg's category-ratio 10 (CR10) scale of 4-5 points. For the next 4 weeks, the patient exercises twice a week with Borg's CR10 exertion level of 6-7 points. In the last 4 weeks, the patient exercises twice a week with Borg's CR10 exertion level of 8-9 points.

The three-month intervention involves twelve weekly calls, with a focus on building rapport (e.g. providing feedback on the baseline assessment); education reinforcement on resistance training; and skill-building (e.g. self-monitoring and resistance training diary). The emphasis is on helping participants to gain the knowledge and skills necessary to achieve targeted intensity. Every 4 weeks, all patients are re-visited by investigators in the hospital.
No Intervention: Control group

The control group receives the baseline treatment for diabetes and sarcopenia:

- Recommendations according to American Diabetes Association guidelines which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients and baseline treatment for sarcopenia (education about sarcopenia and treatment measures such as diet and exercise) and provide basic information on resistance training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance 1 - Handgrip strength
Time Frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome.
Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Physical performance 2 - Gait speed
Time Frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
4-metre gait speed test (the shorter time the better outcome)
Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Physical performance 3 - Short Physical Performance Battery (SPPB)
Time Frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
The Short Physical Performance Battery developed by the National Institute on Aging: scores ranging from 0 (worst) to 12 (best)
Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Muscle mass
Time Frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Upper and lower muscle mass are measured by Bioelectrical impedance analysis (BIA) method, using a machine model named InBody 770: the higher number the better outcome.
Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)
Nutritional status is assessed using the Mini Nutritional Assessment Short-Form (MNA-SF): scores ranging from 0 (worst) to 14 (best)
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)
Health-related Quality of Life
Time Frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)
Health-related Quality of Life is assessed using the health questionnaire 5-level 5 dimensions from EuroQol Group: index scores range from -0.59 to 1; 1 is the best possible health state.
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)
Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)
Time Frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)
Katz Index of Independence in Activities of Daily Living (scores range from 0-worst to 6-best) and Lawton Instrumental Activities of Daily Living Scale (scores range from 0-low function & dependent to 8-high function & independent for women, and 0-worst to 5-best for men)
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Geriatric Hospital

Investigators

  • Study Chair: Huyen TT Vu, PhD, National Geriatric Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NatGerHos-Sarcopenia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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