NCT05071040

Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial

Reduction of Sarcopenia Through a Home-based, App-monitored, Physical Exercise Intervention

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Scientific Institute San Raffaele · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Home-based physical activity	Participants will follow a strength exercise program

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-10-15
• Completion: 2024-10-15
• First posted: 2021-10-07
• Last updated: 2022-05-10

Locations

1 site across 1 country: Italy