Skip to main content
OpenTrials
Completed

NCT Number: NCT03827499

HMB Supplementation in Addition to Multicomponent Exercise in Old Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging Behavior Frail Elderly Syndrome Motor Activity Physical Activity

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sport Sciences

Murcia, San Javier, 30720, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HMB dietary supplementation

Dietary Supplement

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

Multicomponent physical exercise program

Other

Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes

Acronym: HEAL

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2019
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.