'Activity Pacing' in PLWH With Fatigue Symptoms.

Not Applicable

Completed

• Conditions: Hiv
• Interventions: Behavioral: Home-based physical activity

• Registration Number: NCT05194059
• Lead Sponsor: Scientific Institute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-03
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-18
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Home-based physical activity	Participants will follow a personalized activity pacing program for 16 weeks with the support of a heath band and a mobile application for tablet

Primary Outcome Measures

Name	Time	Method
Activity pacing improvement	16 week	To compare the improvement in the physical fitness between the Experimental Group and Control Group

Trial Locations

Locations (1)

Department of Infectious Diseases; 🇮🇹 Milan, Italy