Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Participants have to be willing to be randomised to either intervention group and to follow study protocol
- Men and women
- Aged 70 years and older
- SPPB score ranging between 3 (included) and 9 (included)
- Ability to complete 400-m walk test within 15 minutes without sitting down, the help of another person or the use of a walker
- Presence of low muscle mass according to results from a DXA scan and in agreement with the Foundation for the National Institutes of Health Sarcopenia Project (FNIH) reports.

Exclusion Criteria

- Unable or unwilling to provide informed consent or accept randomisation in either study group
- Plans to relocate out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year
- Nursing-home residence
- Household member enrolled in the study
- Current diagnosis of schizophrenia, other psychotic or bipolar disorder
- Consumption of more than 14 alcoholic drinks per week
- Difficulty communicating with the study personnel due to speech, language, or (non-corrected) hearing problems
- MMSE lower than 24/30
- Severe arthritis (e.g., awaiting joint replacement) that would interfere with the ability to participate fully in either study arm
- Cancer requiring treatment in the past 3 years, except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., early stage breast or prostate cancer)
- Lung disease requiring regular use of supplemental oxygen
- Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents
- Severe cardiovascular disease (including New York Heart Association [NYHA] class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, or uncontrolled angina)
- Upper and/or lower extremity amputation
- Peripheral arterial disease Lériche-Fontaine 3 or 4
- Parkinson*s disease or other progressive neurological disorder
- Renal disease requiring dialysis
- Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline 400-metre walk test
- Current participation in a structured PA program, physical therapy or cardiopulmonary rehabilitation
- Current enrolment in another RCT involving lifestyle, nutrition, or pharmaceutical interventions
- Other medical, psychiatric, or behavioural factors that in the judgment of the principal investigator may interfere with the study participation or the ability to autonomously follow either the MCI or the HALE programmes
- Other illness of such severity that life expectancy is expected to be less than 12 months
- Clinical judgment concerning safety or non-compliance

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primaire efficacy endpoint is the Incidence of mobility disability defined<br /><br>as incident inability of the participant to complete a 400-m walk within 15 min<br /><br>without sitting, help of another person, use of a walker, or stopping for more<br /><br>than 1 minute at a time. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary efficacy endpoint are: changes in physical performance measures,<br /><br>body composition, anthropometric parameters, nutritional status, quality of<br /><br>life, cognitive function and mood, incidence of falls, differences in use of<br /><br>healthcare services and mortality rate.</p><br>