Muscle Quality Index Improvement by Exercise and HMB Oral Supplementation in Older Adults

NCT04734951 | Unknown

• 1 other identifier: 34/20
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aging process is accompanied by a decrease in several biological and physical functions, which have an impact on the perception of well-being and quality of life. Among these, the decrease in muscle mass, strength and power are of particular importance as they are associated with poor cardiorespiratory function, functional limitations and mortality. The muscle quality index (MQI) is considered a key determinant of muscle function in adulthood. The main treatment to preserve muscle mass has been strength exercise and in some cases the use of aids that influence protein metabolism such as beta-hydroxy-beta-methyl butyrate (HMB), but the evidence on this topic is not consistent and is inconclusive. Therefore, the main purpose of this study is to investigate if the combination of a power/resistance exercise program and oral supplementation with HMB can improve the quality mass index in adults aged compared with those received a single exercise program after 14 weeks of intervention.

Conditions

Aging Well

Keywords

Older Adults; Muscle quality index; Exercise training; HMB

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline arm Muscle Quality Index (MQIarm)

  The muscle quality index from dominant arm will be calculated with data obtained from hand grip strength, and lean mass obtained by bioimpedance analysis according with the formula: MQIarm = hand grip strength (kg) / arm lean mass (kg)

  Baseline and 14 weeks

• Mean change from baseline leg Muscle Quality Index (MQIleg)

  The muscle quality index from dominant leg will be calculated with data obtained by isokinetic, and lean mass obtained by bioimpedance analysis according with the formula: MQIleg = peak torque (Nm) / leg lean mass (kg)

  Baseline and 14 weeks

Secondary Outcomes (3)

• Mean change from baseline muscular power

  Baseline and 14 weeks

• Short Physical Performance Battery (SPPB)

  Baseline and 14 weeks

• Health-related quality of life

  Baseline and 14 weeks

Study Arms (2)

Power/resistance exercise

ACTIVE COMPARATOR

Participants on a power/resistance exercise program

Other: Power/resistance exercise program

Power/resistance exercise + HMB

EXPERIMENTAL

Participants on combined power/resistance exercise program + HMB oral supplementation

Other: Power/resistance exercise program; Dietary Supplement: HMB supplementation

Interventions

Power/resistance exercise program OTHER

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; Power/resistance exercise + HMB

HMB supplementation DIETARY_SUPPLEMENT

Daily oral supplementation with 237 ml of a polymeric nutritional formula added with 1.5 g of HMB (Ensure Advance®)

Power/resistance exercise + HMB

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Body mass index 25-30 km/m\^2
• 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

You may not qualify if:

• Osteoporosis
• 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

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead

Related Publications (20)

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Study Officials

• Ariadna d Morales, MD

  National Institute of Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea P Pérez, MSc

CONTACT

52 55 5999 1000; apegueros@gmail.com

Rebeca S Romero, MSc

CONTACT

52 55 5999 1000; calinha@prodigy.net.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Specialist in Physical Activity and Sports Medicine

Model Details: Parallel assignment

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: February 2, 2021
• Study Start: June 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share