Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial

NCT05071040 | Unknown DMC

• 1 other identifier: RF-2019-12370198
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is a pathophysiological process associated with aging and some metabolic conditions characterized by progressive muscle tissue loss, which may lead to loss of strength and performance and increased risk of falls and fractures, physical disability and premature death. With the present project the investigator aim to assess the effect of a feasible exercise program to improve muscle strength (primary outcome), and muscle volume and performance and other measures potentially associated with sarcopenia (secondary outcomes) in elderly and people living with HIV (PLWH) with sarcopenia. The investigators plan to enroll 98 elderly and 98 PLWH in a multicentric, 48-week, randomized, parallel-group, open label, superiority trial comparing the effect of a home-based and app-monitored strength exercise intervention versus no intervention. The investigators expect that participants who exercise will improve strength and other parameters and that improvement at week 12 and week 48 will be higher than in no-exercise controls.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Muscle strenght improvement

  To assess the effect of exercise on muscle strength assess by the handgrip, in elderly people and PLWH, through comparison between an experimental and a control group.

  Week 12

Study Arms (2)

Exercise group

EXPERIMENTAL

Participants will follow a strength exercise program monitored through the use of a specifically designed smartphone application.

Behavioral: Home-based physical activity

Control group

NO INTERVENTION

Continue their daily routine without exercise prescription.

Interventions

Home-based physical activity BEHAVIORAL

Participants will follow a strength exercise program

Exercise group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sedentary
• \>60 year-old in the elderly group or \>50 year-old for the PLWH group;
• with sarcopenia, as defined by both relative loss of muscle mass by bioimpedentiometry (BIA) and low muscle strength by handgrip

You may not qualify if:

• Any disease requiring hospitalization in the 6 weeks before enrollment;
• Medical conditions contraindicating the proposed exercise as established by a sport medicine specialist;
• Current substance or alcohol abuse or use of drugs that may influence balance and coordination;
• Not being able to walk without assistance and to perform the prescribed exercises as by protocol.

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead
• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele Turro

Milan, 20127, Italy

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Paola Cinque, MD

CONTACT

+3902264333160; cinque.paola@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 7, 2021
• Study Start: February 1, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2024
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

IT (1)