Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorNational Geriatric Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Progressive Resistance Training
BehavioralProgressive 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Physical performance 1 - Handgrip strength
Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome.
Time frame
Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)2
Physical performance 2 - Gait speed
4-metre gait speed test (the shorter time the better outcome)
Time frame
Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)3
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)
Time frame
Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)4
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.
Time frame
Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)Secondary outcomes
1
Nutritional status
Nutritional status is assessed using the Mini Nutritional Assessment Short-Form (MNA-SF): scores ranging from 0 (worst) to 14 (best)
Time frame
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)2
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.
Time frame
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)3
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)
Time frame
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)Sponsors and contacts
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Source ClinicalTrials.gov