Effects of an Home-base Physical Activity Program for Counteracting Sarcopenia in Elderly: a Randomized-controlled Trial.
Physical Activity Program for Counteracting Sarcopenia
Sponsors
Source
Istituto Ortopedico Galeazzi
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Is Us Export
No
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
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.
Overall Status
Recruiting
Start Date
2019-09-18
Completion Date
2020-12-20
Primary Completion Date
2020-12-20
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Lower limb strength |
Week 12 |
Enrollment
36
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
Description
Home-based physical activity program
Arm Group Label
Physical activity group
Intervention Type
Dietary Supplement
Intervention Name
Description
Home-based physical activity program and amminoacid supplementation
Arm Group Label
Physical activity and supplementation group
Intervention Type
Other
Intervention Name
Description
No intervention
Arm Group Label
Control group
Eligibility
Criteria
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
Gender
All
Minimum Age
60 Years
Maximum Age
80 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Contact
Location
Facility |
Status |
Contact |
|
IRCCS Istituto Ortopedico Galeazzi Milan 20141 Italy |
Recruiting |
Location Countries
Country
Italy
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Number Of Arms
3
Arm Group
Arm Group Label
Physical activity group
Arm Group Type
Experimental
Arm Group Label
Physical activity and supplementation group
Arm Group Type
Experimental
Arm Group Label
Control group
Arm Group Type
Experimental
Firstreceived Results Date
N/A
Acronym
EXERSARCO
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)
Study First Submitted
November 13, 2019
Study First Submitted Qc
November 20, 2019
Study First Posted
November 21, 2019
Last Update Submitted
November 20, 2019
Last Update Submitted Qc
November 20, 2019
Last Update Posted
November 21, 2019
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.