SarcopeniaEXERSARCONCT04172285
Physical Activity Program for Counteracting Sarcopenia
A study testing Physical activity and Physical activity and supplementation in people with Sarcopenia, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 strangth and performance and increase risk of falls and fractures, physical disability and premature death. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Physical activity and Physical activity and supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 18 Sep 2019to 20 Dec 2021
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary lifestyle.
- Cognitively intact.
- Autonomous walking.
- Acceptance of informed consent.
Who cannot join
- Body mass index lower than 18.5 and uppen than 40 kg/m2.
- History of cancer.
- Pacemaker user.
- History of epileptic episodes.
- Endocrine-metabolic, neurological, muscular and ortopedic pathologies that affect movement functions.
- Bone fractures that influence movement functions.
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- Smoking.
- Surgical treatments in the prior 6 months.
- Use of antieptilectics, glucocorticoids, rhGH and testosterone.
- Hepatic and muscular pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Home-base Physical Activity Program for Counteracting Sarcopenia in Elderly: a Randomized-controlled Trial.
Sarcopenia is a pathophysiological process associated with aging and some metabolic conditions characterized by progressive muscle tissue loss, which may lead to loss of strangth and performance and increase risk of falls and fractures, physical disability and premature death. Therefore, it is necessary to identify personalized programs of physical activity and supplementation for elderly population in order to improve their physical functions, muscle strengh and body composition.
With the present project we aime to assess the effect of a feasible home-based exercise program coupled with food supplementation to improve muscle strength, muscle volume and muscle physical performance potentially associated with sarcopenia in elderly people.
- Conditions
- Sarcopenia
- Being tested
- Physical activity, Physical activity and supplementation, Control
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Home-based physical activity program
Physical activity and supplementationDietary supplement
Home-based physical activity program and amminoacid supplementation
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Physical activity group | Experimental | Not described Receives: Behavioral: Physical activity |
| Physical activity and supplementation group | Experimental | Not described Receives: Dietary Supplement: Physical activity and supplementation |
| Control group | Experimental | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb strength
Assessed by chair stand test
Measured: Baseline and Week 24
Secondary outcomes (5)
Body composition
Assessed by Whole-body dual energy X-ray absorptiometry
Measured: Baseline and Week 24
Quantify thigh cross sectional area
Assessed by Dixon magnetic resonance imaging
Measured: Baseline and Week 24
Maximum isometric force that a hand can squeeze
Assessed by Hand Grip Strength test
Measured: Baseline and Week 24
Maximal Isometric Strength of Knee flexors and extensors
Assessed by a belt-stabilized dynamometer
Measured: Baseline AND Week 24
Dynamic balance and gait deficits
Assessed by mini-BESTest
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start18 Sep 2019
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Dec 2021 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172285
- Sponsor's protocol ID
- EXERSARCO
- Acronym
- EXERSARCO
- Status last verified
- Feb 2021
- First submitted
- 13 Nov 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Home-base Physical Activity Program for Counteracting Sarcopenia in Elderly: a Randomized-controlled Trial.
- ClinicalTrials.gov ID
- NCT04172285
- Acronym / sponsor ID
- EXERSARCO / EXERSARCO
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 21 Nov 2019 (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 strangth and performance and increase risk of falls and fractures, physical disability and premature death. Therefore, it is necessary to identify personalized programs of physical activity and supplementation for elderly population in order to improve their physical functions, muscle strengh and body composition.
With the present project we aime to assess the effect of a feasible home-based exercise program coupled with food supplementation to improve muscle strength, muscle volume and muscle physical performance potentially associated with sarcopenia in elderly people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical activity group | Experimental | Behavioral: Physical activity |
| Physical activity and supplementation group | Experimental | Dietary Supplement: Physical activity and supplementation |
| Control group | Experimental | Other: Control |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sedentary lifestyle.
- Cognitively intact.
- Autonomous walking.
- Acceptance of informed consent.
Key exclusion criteria (10 listed)
- Body mass index lower than 18.5 and uppen than 40 kg/m2.
- History of cancer.
- Pacemaker user.
- History of epileptic episodes.
- Endocrine-metabolic, neurological, muscular and ortopedic pathologies that affect movement functions.
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 |
|---|---|---|
| Physical activityHome-based physical activity program | Behavioural | Physical activity group |
| Physical activity and supplementationHome-based physical activity program and amminoacid supplementation | Dietary supplement | Physical activity and supplementation group |
| ControlNo intervention | Other | Control group |
Primary outcome
Lower limb strength
Time frame: Baseline and Week 24
Assessed by chair stand test
5 secondary outcomes
Body composition
Time frame: Baseline and Week 24
Quantify thigh cross sectional area
Time frame: Baseline and Week 24
Maximum isometric force that a hand can squeeze
Time frame: Baseline and Week 24
Maximal Isometric Strength of Knee flexors and extensors
Time frame: Baseline AND Week 24
Dynamic balance and gait deficits
Time frame: Baseline and Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Physical activity and supplementation in people with Sarcopenia, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 4 inclusion and 10 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 9 Feb 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limb strength (time frame: Baseline and Week 24). 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 9 Feb 2021.