- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04172285
Physical Activity Program for Counteracting Sarcopenia (EXERSARCO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Milan, Italy, 20141
- IRCCS Istituto Ortopedico Galeazzi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sedentary lifestyle.
- Cognitively intact.
- Autonomous walking.
- Acceptance of informed consent.
Exclusion Criteria:
- 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.
- Smoking.
- Surgical treatments in the prior 6 months.
- Use of antieptilectics, glucocorticoids, rhGH and testosterone.
- Hepatic and muscular pathologies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control group
|
No intervention
|
Experimental: Physical activity group
|
Home-based physical activity program
|
Experimental: Physical activity and supplementation group
|
Home-based physical activity program and amminoacid supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower limb strength
Time Frame: Baseline and Week 24
|
Assessed by chair stand test
|
Baseline and Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: Baseline and Week 24
|
Assessed by Whole-body dual energy X-ray absorptiometry
|
Baseline and Week 24
|
Quantify thigh cross sectional area
Time Frame: Baseline and Week 24
|
Assessed by Dixon magnetic resonance imaging
|
Baseline and Week 24
|
Maximum isometric force that a hand can squeeze
Time Frame: Baseline and Week 24
|
Assessed by Hand Grip Strength test
|
Baseline and Week 24
|
Maximal Isometric Strength of Knee flexors and extensors
Time Frame: Baseline AND Week 24
|
Assessed by a belt-stabilized dynamometer
|
Baseline AND Week 24
|
Dynamic balance and gait deficits
Time Frame: Baseline and Week 24
|
Assessed by mini-BESTest
|
Baseline and Week 24
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXERSARCO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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