'Activity Pacing' in PLWH With Fatigue Symptoms. (ActiPacMAN)

ActiPacMAN: 'Activity Pacing' in PLWH With Fatigue Symptoms. Monitoring Through the Combined Use of Actigraphy and Mobile App Notifications

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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Behavioral: Home-based physical activity

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20127
    • Department of Infectious Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants will follow a personalized activity pacing program for 16 weeks with the support of a heath band and a mobile application for tablet	Behavioral: Home-based physical activity; Participants will follow a personalized activity pacing program
No Intervention: Control Group; Participants will follow a personalized activity pacing program for 16 weeks without any other support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity pacing improvement	To compare the improvement in the physical fitness between the Experimental Group and Control Group	16 week

Collaborators and Investigators

• Sponsor: Scientific Institute San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: ActiPacMAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No