Clinical trial NCT06337357: Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia
Official title: Evaluating Resistance Training for Sarcopenia in Older Patients With Type 2 Diabetes: Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Diabetes
Keywords: Sarcopenia
Diabetes
Resistance training
Lead sponsor: National Geriatric Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-29
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Physical performance 1 - Handgrip strength
timeFrame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
measure: Physical performance 2 - Gait speed
timeFrame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
measure: Physical performance 3 - Short Physical Performance Battery (SPPB)
timeFrame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
measure: Muscle mass
timeFrame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Secondary outcomes:
measure: Nutritional status
timeFrame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)
measure: Health-related Quality of Life
timeFrame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)
measure: Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)
timeFrame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Geriatric Hospital
Study officials:
affiliation: National Geriatric Hospital
name: Huyen TT Vu, PhD
role: STUDY_CHAIR
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