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

NCT06337357 | Recruiting DMC

• 1 other identifier: NatGerHos-Sarcopenia
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Diabetes

Keywords

Sarcopenia; Diabetes; Resistance training

Outcome Measures

Primary Outcomes (4)

• Physical performance 1 - Handgrip strength

  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

  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)

  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

  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 Outcomes (3)

• Nutritional status

  Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)

• Health-related Quality of Life

  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)

  Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Progressive Resistance Training BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Geriatric Hospital: lead

Study Sites (1)

National Geriatric Hospital

Hanoi, 100000, Vietnam

RECRUITING

Related Publications (40)

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MeSH Terms

Conditions

Sarcopenia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Huyen TT Vu, PhD

  National Geriatric Hospital

  STUDY CHAIR

Central Study Contacts

Anh N Trinh, MD

CONTACT

(+84) 912760684; drtrinhanh.endo@gmail.com

Tam N Nguyen, PhD

CONTACT

+84979221905; ngoctam@hmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, Principal Investigator and Sponsor

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 29, 2024
• Study Start: April 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

VN (1)