Physical Activity Program for Counteracting Sarcopenia (EXERSARCO)

February 8, 2021 updated by: Istituto Ortopedico Galeazzi

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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20141
        • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Control
No intervention
Experimental: Physical activity group
Behavioral: Physical activity
Home-based physical activity program
Experimental: Physical activity and supplementation group
Dietary supplement: Physical activity and supplementation
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

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2019

Primary Completion (Anticipated)

December 20, 2021

Study Completion (Anticipated)

December 20, 2021

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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