Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial
Primary Purpose
Sarcopenia
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Home-based physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- Sedentary
- >60 year-old in the elderly group or >50 year-old for the PLWH group;
- with sarcopenia, as defined by both relative loss of muscle mass by bioimpedentiometry (BIA) and low muscle strength by handgrip
Exclusion Criteria:
- Any disease requiring hospitalization in the 6 weeks before enrollment;
- Medical conditions contraindicating the proposed exercise as established by a sport medicine specialist;
- Current substance or alcohol abuse or use of drugs that may influence balance and coordination;
- Not being able to walk without assistance and to perform the prescribed exercises as by protocol.
Sites / Locations
- IRCCS Ospedale San Raffaele TurroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Control group
Arm Description
Participants will follow a strength exercise program monitored through the use of a specifically designed smartphone application.
Continue their daily routine without exercise prescription.
Outcomes
Primary Outcome Measures
Muscle strenght improvement
To assess the effect of exercise on muscle strength assess by the handgrip, in elderly people and PLWH, through comparison between an experimental and a control group.
Secondary Outcome Measures
Full Information
NCT ID
NCT05071040
First Posted
September 24, 2021
Last Updated
May 4, 2022
Sponsor
Scientific Institute San Raffaele
Collaborators
Istituto Ortopedico Galeazzi
1. Study Identification
Unique Protocol Identification Number
NCT05071040
Brief Title
Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial
Official Title
Reduction of Sarcopenia Through a Home-based, App-monitored, Physical Exercise Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scientific Institute San Raffaele
Collaborators
Istituto Ortopedico Galeazzi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
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 strength and performance and increased risk of falls and fractures, physical disability and premature death. With the present project the investigator aim to assess the effect of a feasible exercise program to improve muscle strength (primary outcome), and muscle volume and performance and other measures potentially associated with sarcopenia (secondary outcomes) in elderly and people living with HIV (PLWH) with sarcopenia. The investigators plan to enroll 98 elderly and 98 PLWH in a multicentric, 48-week, randomized, parallel-group, open label, superiority trial comparing the effect of a home-based and app-monitored strength exercise intervention versus no intervention. The investigators expect that participants who exercise will improve strength and other parameters and that improvement at week 12 and week 48 will be higher than in no-exercise controls.
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
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Participants will follow a strength exercise program monitored through the use of a specifically designed smartphone application.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Continue their daily routine without exercise prescription.
Intervention Type
Behavioral
Intervention Name(s)
Home-based physical activity
Intervention Description
Participants will follow a strength exercise program
Primary Outcome Measure Information:
Title
Muscle strenght improvement
Description
To assess the effect of exercise on muscle strength assess by the handgrip, in elderly people and PLWH, through comparison between an experimental and a control group.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Sedentary
>60 year-old in the elderly group or >50 year-old for the PLWH group;
with sarcopenia, as defined by both relative loss of muscle mass by bioimpedentiometry (BIA) and low muscle strength by handgrip
Exclusion Criteria:
Any disease requiring hospitalization in the 6 weeks before enrollment;
Medical conditions contraindicating the proposed exercise as established by a sport medicine specialist;
Current substance or alcohol abuse or use of drugs that may influence balance and coordination;
Not being able to walk without assistance and to perform the prescribed exercises as by protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Cinque, MD
Phone
+3902264333160
Email
cinque.paola@hsr.it
Facility Information:
Facility Name
IRCCS Ospedale San Raffaele Turro
City
Milano
ZIP/Postal Code
20127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Cinque, MD, Ph.D.
Phone
+3902264333160
Email
cinque.paola@hsr.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial
We'll reach out to this number within 24 hrs