Back to results'Activity Pacing' in PLWH With Fatigue Symptoms. (ActiPacMAN)
Primary Purpose
Hiv
Status
Completed
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 Hiv
Eligibility Criteria
Inclusion Criteria:
- of age ≥18 years;
- either sedentary or already practicing mild/moderate physical activity (at least 150 minutes of moderate-intensity physical activity throughout the week);
- able to sign the informed consent.
Exclusion Criteria:
The study will exclude HIV+ individuals:
- with any HIV-related disease requiring hospitalization in the 6 weeks before enrolment;
- with medical conditions (e.g. neurologic, muscular-skeletal, cardiovascular diseases) contraindicating non agonistic exercise, as established by a sport medicine specialist;
- currently abusing of substance or alcohol;
- already performing physical activity at higher level than the current WHO recommendations (30 minutes of moderate activity 5 times a week).
Sites / Locations
- Department of Infectious Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
Participants will follow a personalized activity pacing program for 16 weeks with the support of a heath band and a mobile application for tablet
Participants will follow a personalized activity pacing program for 16 weeks without any other support
Outcomes
Primary Outcome Measures
Activity pacing improvement
To compare the improvement in the physical fitness between the Experimental Group and Control Group
Secondary Outcome Measures
Full Information
NCT ID
NCT05194059
First Posted
January 3, 2022
Last Updated
January 16, 2023
Sponsor
Scientific Institute San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT05194059
Brief Title
'Activity Pacing' in PLWH With Fatigue Symptoms.
Acronym
ActiPacMAN
Official Title
ActiPacMAN: 'Activity Pacing' in PLWH With Fatigue Symptoms. Monitoring Through the Combined Use of Actigraphy and Mobile App Notifications
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scientific Institute San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Physical activity helps to improve health and prevent chronic diseases. However, the fatigue usually hampers the training and execution of physical exercises, especially in people with chronic fatigue syndromes (CFCs), such as persons living with HIV (PLWH). We hypothesize that the "activity pacing", i.e. the strategy to optimize daily physical activity into manageable exercises in a way that should not exacerbate fatigue symptoms, may help a progressive improvement in physical activity of a group of PLWH with fatigue symptoms. Motivation and adherence to exercise will be monitored through the use of digital supports.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants will follow a personalized activity pacing program for 16 weeks with the support of a heath band and a mobile application for tablet
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will follow a personalized activity pacing program for 16 weeks without any other support
Intervention Type
Behavioral
Intervention Name(s)
Home-based physical activity
Intervention Description
Participants will follow a personalized activity pacing program
Primary Outcome Measure Information:
Title
Activity pacing improvement
Description
To compare the improvement in the physical fitness between the Experimental Group and Control Group
Time Frame
16 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
of age ≥18 years;
either sedentary or already practicing mild/moderate physical activity (at least 150 minutes of moderate-intensity physical activity throughout the week);
able to sign the informed consent.
Exclusion Criteria:
The study will exclude HIV+ individuals:
with any HIV-related disease requiring hospitalization in the 6 weeks before enrolment;
with medical conditions (e.g. neurologic, muscular-skeletal, cardiovascular diseases) contraindicating non agonistic exercise, as established by a sport medicine specialist;
currently abusing of substance or alcohol;
already performing physical activity at higher level than the current WHO recommendations (30 minutes of moderate activity 5 times a week).
Facility Information:
Facility Name
Department of Infectious Diseases
City
Milan
ZIP/Postal Code
20127
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
'Activity Pacing' in PLWH With Fatigue Symptoms.
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