Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial

NCT ID: NCT05071040

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-10-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise group

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

Group Type: EXPERIMENTAL

Home-based physical activity

Intervention Type: BEHAVIORAL

Participants will follow a strength exercise program

Control group

Continue their daily routine without exercise prescription.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home-based physical activity

Participants will follow a strength exercise program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: collaborator

Scientific Institute San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Paola Cinque

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele Turro

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paola Cinque, MD

Role: CONTACT

cinque.paola@hsr.it

+3902264333160

Facility Contacts

Paola Cinque, MD, Ph.D.

Role: primary

cinque.paola@hsr.it

+3902264333160

Other Identifiers

RF-2019-12370198

Identifier Type: -

Identifier Source: org_study_id