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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06337357
• Other study ID #: NatGerHos-Sarcopenia
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: National Geriatric Hospital
• Contact: Anh N Trinh, MD
• Phone: (+84) 912760684
• Email: drtrinhanh.endo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Vietnam	National Geriatric Hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
National Geriatric Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Nutritional status	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)
Secondary	Health-related Quality of Life	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)
Secondary	Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)	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)