Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05071040

Enrollment

198

Registered

2021-10-07

Start date

2022-02-01

Completion date

2024-10-15

Last updated

2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

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.

Interventions

BEHAVIORALHome-based physical activity

Participants will follow a strength exercise program

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Muscle strenght improvement	Week 12	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.

Countries

Italy

Contacts

Primary ContactPaola Cinque, MD

cinque.paola@hsr.it+3902264333160

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026