Muscle Quality Index Improvement by Exercise and HMB Oral Supplementation in Older Adults
NCT ID: NCT04734951
Last Updated: 2023-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
76 participants
INTERVENTIONAL
2023-06-30
2024-08-31
Brief Summary
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Detailed Description
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Participants: Adults between 65-75 years old, with a body mass index between 25-30 kg/m\^2, sedentaries, non-smokers, with compensated comorbidities, and who do not consume nutritional supplements will be recruited. Participants with uncompensated metabolic diseases, with high risk of falls (evaluated with Tinetti scale), frailty syndrome, and b2-adrenergic agonists, glucocorticoids, diuretics or peripheral vasodilators users will not be recruited.
Intervention: Participants will be randomized to 1) power/resistance exercise program (GEx), 2) power/resistance exercise program + HMB group (GExHMB) with computer-generated random numbers. The exercise program will consist of training to improve muscular strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. Every training session will consist of 15 minutes of warm-up, 40 to 60 minutes of power/resistance training, neuromuscular and aerobic exercises, and 15 minutes of cool-down. The power/resistance and neuromuscular training will be performed 3 days/week, 2-5 sets, 5-15 repetitions for each exercise according to the recommendation of the American College of Sports Medicine training progression models; the aerobic exercise will be performed 2 days/week. All exercises will be performed at moderate intensity and will take place in the NIR Sports Medicine therapeutic gym.
Oral supplementation with HMB will be from a commercial polymeric formula in liquid form (Ensure Advanced®, 230 ml); the supplement intake will be 1 bottle/day. All patients, regardless of the intervention, will be monitored by sports medicine physicians and nutritionists in order to promote adherence to treatment.
The muscle quality index (MQI) will be obtained from the determination of muscular strength by isokinetic dynamometry (at 60°/s) for the lower extremities and by hand dynamometry for the upper extremities; the lean segmental mass in the upper and lower extremities will be determined by 3-frequency electronic bioimpedance analysis. The MQI will be calculated from the muscular strength divided by the muscular mass.
Lower extremities muscular power will be determined by isokinetic dynamometry at 180°/s, physical performance will be assessed by the Short Physical Performance battery (SPPB) and quality of life perception will be evaluated by the EuroQoL-5D questionnaire. As part of the safety measures for the participants, liver function will be monitored by laboratory tests (liver enzyme profile and general urine test) which will be performed at the NIR laboratory.
For each participant the study length will be 14 weeks with 61 exercise sessions for the GEx and GExHMB groups and 98 days of oral supplementation for the GExHMB group. The beginning of the study corresponds to session 1 of exercise and day 1 of supplementation intake. Initial evaluations will be performed 5 days prior to the start of the intervention, while final evaluations will be conducted at the end of 14 weeks of follow-up (2 days after the last day of the intervention). Data will be recorded by study investigators blinded to participant assignment.
Comparison: Comparison group will receive the unique intervention of a strength/resistance exercise program.
Outcomes: The primary outcome is the upper and lower extremities MQI mean change. The secondary outcomes are mean changes in muscular power, physical performance, and health related quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Power/resistance exercise
Participants on a power/resistance exercise program
Power/resistance exercise program
participants will complete a power/resistance program during 14 weeks. The exercise program will consist of training to improve muscle strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. The intensity will be set according the estimated repetition to failure.
Power/resistance exercise + HMB
Participants on combined power/resistance exercise program + HMB oral supplementation
Power/resistance exercise program
participants will complete a power/resistance program during 14 weeks. The exercise program will consist of training to improve muscle strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. The intensity will be set according the estimated repetition to failure.
HMB supplementation
Daily oral supplementation with 237 ml of a polymeric nutritional formula added with 1.5 g of HMB (Ensure Advance®)
Interventions
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Power/resistance exercise program
participants will complete a power/resistance program during 14 weeks. The exercise program will consist of training to improve muscle strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. The intensity will be set according the estimated repetition to failure.
HMB supplementation
Daily oral supplementation with 237 ml of a polymeric nutritional formula added with 1.5 g of HMB (Ensure Advance®)
Eligibility Criteria
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Inclusion Criteria
* Appendicular skeletal muscle mass index in women ≥ 5.0 kg/m\^2 and men ≥ 6.0 kg/m\^2
* No regular exercise
* Non-smokers
* Compensated comorbidities
* Without consumption of nutritional supplements
Exclusion Criteria
* Cardiovascular diseases (recent heart attack, unstable angina, heart failure, complete atrioventricular block)
* Musculoskeletal injuries
* Severe cognitive impairment
* Major depressive disorder
* Thyroid diseases
* Anemia with no response to previous treatment in the last 3 months
* b2-adrenergic agonists, glucocorticoids, diuretics or peripheral vasodilators users
* With amino acid and vitamin D supplementation or suspended with less than 3 months
* Data of renal insufficiency
* Chronic obstructive pulmonary disease
* Malabsorption syndrome associated with malnutrition
* High risk of falls evaluated with the Tinetti scale (score ≤19)
* Frailty syndrome
65 Years
75 Years
ALL
No
Sponsors
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Instituto Nacional de Rehabilitacion
OTHER_GOV
Responsible Party
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Ariadna del Villar Morales
Medical Specialist in Physical Activity and Sports Medicine
Principal Investigators
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Ariadna d Morales, MD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Rehabilitation
Central Contacts
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References
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Other Identifiers
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34/20
Identifier Type: -
Identifier Source: org_study_id
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