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Physical Activity Program for Counteracting Sarcopenia (EXERSARCO)

Primary Purpose

Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Physical activity
Physical activity and supplementation
Control
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IRCCS Istituto Ortopedico Galeazzi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Physical activity group

Physical activity and supplementation group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Lower limb strength
Assessed by chair stand test

Secondary Outcome Measures

Body composition
Assessed by Whole-body dual energy X-ray absorptiometry
Quantify thigh cross sectional area
Assessed by Dixon magnetic resonance imaging
Maximum isometric force that a hand can squeeze
Assessed by Hand Grip Strength test
Maximal Isometric Strength of Knee flexors and extensors
Assessed by a belt-stabilized dynamometer
Dynamic balance and gait deficits
Assessed by mini-BESTest

Full Information

First Posted
November 13, 2019
Last Updated
February 8, 2021
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT04172285
Brief Title
Physical Activity Program for Counteracting Sarcopenia
Acronym
EXERSARCO
Official Title
Effects of an Home-base Physical Activity Program for Counteracting Sarcopenia in Elderly: a Randomized-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity group
Arm Type
Experimental
Arm Title
Physical activity and supplementation group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
Home-based physical activity program
Intervention Type
Dietary Supplement
Intervention Name(s)
Physical activity and supplementation
Intervention Description
Home-based physical activity program and amminoacid supplementation
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Lower limb strength
Description
Assessed by chair stand test
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Body composition
Description
Assessed by Whole-body dual energy X-ray absorptiometry
Time Frame
Baseline and Week 24
Title
Quantify thigh cross sectional area
Description
Assessed by Dixon magnetic resonance imaging
Time Frame
Baseline and Week 24
Title
Maximum isometric force that a hand can squeeze
Description
Assessed by Hand Grip Strength test
Time Frame
Baseline and Week 24
Title
Maximal Isometric Strength of Knee flexors and extensors
Description
Assessed by a belt-stabilized dynamometer
Time Frame
Baseline AND Week 24
Title
Dynamic balance and gait deficits
Description
Assessed by mini-BESTest
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
ZIP/Postal Code
20141
Country
Italy

12. IPD Sharing Statement

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Physical Activity Program for Counteracting Sarcopenia

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