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HMB Supplementation in Addition to Multicomponent Exercise in Old Adults (HEAL)

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ClinicalTrials.gov Identifier: NCT03827499
Recruitment Status : Enrolling by invitation
First Posted : February 1, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Javier Courel Ibáñez, Universidad de Murcia

Study Description
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Brief Summary:
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown. Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.

Condition or disease Intervention/treatment Phase
Aging Frail Elderly Syndrome Physical Activity Dietary Supplement: HMB dietary supplementation Other: Multicomponent physical exercise program Not Applicable

Detailed Description:

Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown.

Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.

The findings of the HEAL study will help professionals from public health systems to identify cost-effectiveness and innovative actions to improve older people's health and quality of life, and endorse exercise practice in older adults living in nursing homes.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes
Actual Study Start Date : March 30, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ex-HMB
HMB dietary supplementation and Multicomponent physical exercise program
 Dietary Supplement: HMB dietary supplementation
Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention

Other: Multicomponent physical exercise program
Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.
Experimental: NoEx-HMB
HMB Dietary supplementation
 Dietary Supplement: HMB dietary supplementation
Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention
Placebo Comparator: Ex-Plac
Multicomponent physical exercise program
 Other: Multicomponent physical exercise program
Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.
No Intervention: Controls
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score [ Time Frame: Baseline to 25 Weeks ]
    Summary scores range from 0-12 and higher scores denote higher physical performance.


Secondary Outcome Measures :
  1. Change in Handgrip strength (kg) [ Time Frame: Baseline to 25 Weeks ]
    Using a dynamometer

  2. Change in lower-body strength (kg) [ Time Frame: Baseline to 25 Weeks ]
    Seated leg press one-repetition maximun test

  3. Change in upper-body strength (kg) [ Time Frame: Baseline to 25 Weeks ]
    Vertical bench press one-repetition maximun test

  4. Change in lower-body strength power output (m/s) [ Time Frame: Baseline to 25 Weeks ]
    Seated leg press load-velocity profile

  5. Change in upper-body strength power output (m/s) [ Time Frame: Baseline to 25 Weeks ]
    Vertical bench press load-velocity profile

  6. Change in frailty (score) [ Time Frame: Baseline to 25 Weeks ]
    Frailty phenotype determination using Fried's criteria

  7. Change in lean body mass (kg) [ Time Frame: Baseline to Week 25 ]
    Change in lean body mass using dual energy x-ray absorptiometry

  8. Change in lipid profile [ Time Frame: Baseline to Week 25 ]
    Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL)

  9. Change in glycaemic profile [ Time Frame: Baseline to Week 25 ]
    Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL)

  10. Change in Thyroid-Stimulating Hormone (mIU/L) [ Time Frame: Baseline to Week 25 ]
  11. Change in Disability (Lawton index scores) [ Time Frame: Baseline to 25 Weeks ]
    Disability in instrumental activities of daily living.

  12. Change in Disability (Barthel index scores) [ Time Frame: Baseline to 25 Weeks ]
    Disability in basic activities of daily living

  13. Change in Comorbidity (score) [ Time Frame: Baseline to 25 Weeks ]
    When a participant presents two or more geriatric syndromes from a list of selected geriatric syndromes

  14. Change in cognitive function (score) [ Time Frame: Baseline to 25 Weeks ]
    Using the Mini-Mental State Examination

  15. Change in depression (score) [ Time Frame: Baseline to 25 Weeks ]
    Using the 15-item Yesavage geriatric depression


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged ≥70 years living in a nursing home
  • Be able to follow an active physical rehabilitation program
  • Be able to read and wright
  • Voluntary participation
  • Capable and willing to provide an informed consent

Exclusion Criteria:

  • Acute heart attack (recent 3-6 months) or unstable angina
  • Uncontrolled atrial or ventricular arrhythmias
  • Aortic dissecting aneurysm
  • Severe aortic stenosis
  • Acute endocarditis / pericarditis
  • Uncontrolled high blood pressure (>180/100 mmHg)
  • Acute thromboembolism
  • Acute or severe heart failure
  • Acute or severe respiratory failure
  • Uncontrolled postural hypotension
  • Uncontrolled acute decompensated diabetes mellitus or low blood sugar
  • A recent fracture in the last month.
  • Coincident participation in any intervention trial
  • HMB contraindication, intolerance, or allergy
  • Community-dwelling people
  • Have regularly performed exercise (>20 minutes >3 days/week) in the last 3 months
  • Malignant diseases (exceptions: basal or squamous-cell skin carcinoma or carcinoma in situ of the uterine cervix)
  • Revascularization within 1 year
  • Severe loss of vision, hearing, or communicative ability
  • Conditions preventing cooperation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827499


Locations
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Spain
Faculty of Sport Sciences
Murcia, San Javier, Spain, 30720
Sponsors and Collaborators
Universidad de Murcia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Javier Courel Ibáñez, Ph.D, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT03827499    
Other Study ID Numbers: 2131/2018
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No