NCT03827499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3.8 years

First QC Date

January 30, 2019

Last Update Submit

May 9, 2023

Conditions

AgingFrail Elderly SyndromePhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score

    Summary scores range from 0-12 and higher scores denote higher physical performance.

    Baseline to 25 Weeks

Secondary Outcomes (15)

  • Change in Handgrip strength (kg)

    Baseline to 25 Weeks

  • Change in lower-body strength (kg)

    Baseline to 25 Weeks

  • Change in upper-body strength (kg)

    Baseline to 25 Weeks

  • Change in lower-body strength power output (m/s)

    Baseline to 25 Weeks

  • Change in upper-body strength power output (m/s)

    Baseline to 25 Weeks

  • +10 more secondary outcomes

Study Arms (4)

Ex-HMB

EXPERIMENTAL

HMB dietary supplementation and Multicomponent physical exercise program

Dietary Supplement: HMB dietary supplementationOther: Multicomponent physical exercise program

NoEx-HMB

EXPERIMENTAL

HMB Dietary supplementation

Dietary Supplement: HMB dietary supplementation

Ex-Plac

PLACEBO COMPARATOR

Multicomponent physical exercise program

Other: Multicomponent physical exercise program

Controls

NO INTERVENTION

No intervention

Interventions

HMB dietary supplementationDIETARY_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

Ex-HMBNoEx-HMB
Multicomponent physical exercise programOTHER

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

Ex-HMBEx-Plac

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport Sciences

Murcia, San Javier, 30720, Spain

Location

Related Publications (1)

  • Courel-Ibanez J, Pallares JG; HEAL study group. Effects of beta-hydroxy-beta-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.

    PMID: 31277595DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

March 30, 2019

Primary Completion

January 30, 2023

Study Completion

April 30, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

ES(1)