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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05071040
Other study ID # RF-2019-12370198
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date October 15, 2024

Study information

Verified date May 2022
Source Scientific Institute San Raffaele
Contact Paola Cinque, MD
Phone +3902264333160
Email cinque.paola@hsr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 198
Est. completion date October 15, 2024
Est. primary completion date October 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Home-based physical activity
Participants will follow a strength exercise program

Locations

Country Name City State
Italy IRCCS Ospedale San Raffaele Turro Milano

Sponsors (2)

Lead Sponsor Collaborator
Scientific Institute San Raffaele Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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