SarcopeniaNCT05071040
Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial
A study testing Home-based physical activity in people with Sarcopenia, run by Scientific Institute San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Home-based physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele Turro
Milan, 20127
Paola Cinque, MD, Ph.D., +3902264333160, cinque.paola@hsr.it
About this study
Official title: Reduction of Sarcopenia Through a Home-based, App-monitored, Physical Exercise Intervention
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
- Being tested
- Home-based physical activity
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based physical activityBehavioural
Participants will follow a strength exercise program
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Participants will follow a strength exercise program monitored through the use of a specifically designed smartphone application. Receives: Behavioral: Home-based physical activity |
| Control group | No intervention | Continue their daily routine without exercise prescription. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start1 Feb 2022
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Responsible party
- Principal investigator, Paola Cinque, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071040
- Sponsor's protocol ID
- RF-2019-12370198
- Status last verified
- May 2022
- First submitted
- 24 Sep 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Sarcopenia Through a Home-based, App-monitored, Physical Exercise Intervention
- ClinicalTrials.gov ID
- NCT05071040
- Acronym / sponsor ID
- RF-2019-12370198
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Collaborators
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Home-based physical activityParticipants will follow a strength exercise program monitored through the use of a specifically designed smartphone application. |
| Control group | No intervention | –Continue their daily routine without exercise prescription. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based physical activityParticipants will follow a strength exercise program | Behavioural | Exercise group |
Primary outcome
Muscle strenght improvement
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based physical activity in people with Sarcopenia, run by Scientific Institute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Cinque, MD (+3902264333160, cinque.paola@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strenght improvement (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022; AzTrials last refreshed its copy on 29 Oct 2026.