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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 30, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE March 30, 2019
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Change in Handgrip strength (kg) [ Time Frame: Baseline to 25 Weeks ]
    Using a dynamometer
  • Change in lower-body strength (kg) [ Time Frame: Baseline to 25 Weeks ]
    Seated leg press one-repetition maximun test
  • Change in upper-body strength (kg) [ Time Frame: Baseline to 25 Weeks ]
    Vertical bench press one-repetition maximun test
  • Change in lower-body strength power output (m/s) [ Time Frame: Baseline to 25 Weeks ]
    Seated leg press load-velocity profile
  • Change in upper-body strength power output (m/s) [ Time Frame: Baseline to 25 Weeks ]
    Vertical bench press load-velocity profile
  • Change in frailty (score) [ Time Frame: Baseline to 25 Weeks ]
    Frailty phenotype determination using Fried's criteria
  • Change in lean body mass (kg) [ Time Frame: Baseline to Week 25 ]
    Change in lean body mass using dual energy x-ray absorptiometry
  • 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)
  • Change in glycaemic profile [ Time Frame: Baseline to Week 25 ]
    Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL)
  • Change in Thyroid-Stimulating Hormone (mIU/L) [ Time Frame: Baseline to Week 25 ]
  • Change in Disability (Lawton index scores) [ Time Frame: Baseline to 25 Weeks ]
    Disability in instrumental activities of daily living.
  • Change in Disability (Barthel index scores) [ Time Frame: Baseline to 25 Weeks ]
    Disability in basic activities of daily living
  • 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
  • Change in cognitive function (score) [ Time Frame: Baseline to 25 Weeks ]
    Using the Mini-Mental State Examination
  • Change in depression (score) [ Time Frame: Baseline to 25 Weeks ]
    Using the 15-item Yesavage geriatric depression
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HMB Supplementation in Addition to Multicomponent Exercise in Old Adults
Official Title  ICMJE Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Aging
  • Frail Elderly Syndrome
  • Physical Activity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Ex-HMB
    HMB dietary supplementation and Multicomponent physical exercise program
    Interventions:
    • Dietary Supplement: HMB dietary supplementation
    • Other: Multicomponent physical exercise program
  • Experimental: NoEx-HMB
    HMB Dietary supplementation
    Intervention: Dietary Supplement: HMB dietary supplementation
  • Placebo Comparator: Ex-Plac
    Multicomponent physical exercise program
    Intervention: Other: Multicomponent physical exercise program
  • No Intervention: Controls
    No intervention
Publications * Courel-Ibáñez J, Pallarés JG; HEAL study group. Effects of β-hydroxy-β-methylbutyrate (HMB) supplementation in addition to multicomponent exercise in adults older than 70 years living in nursing homes, a cluster randomized placebo-controlled trial: the HEAL study protocol. BMC Geriatr. 2019 Jul 5;19(1):188. doi: 10.1186/s12877-019-1200-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2022
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827499
Other Study ID Numbers  ICMJE 2131/2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Javier Courel Ibáñez, Universidad de Murcia
Study Sponsor  ICMJE Universidad de Murcia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad de Murcia
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP