'Activity Pacing' in PLWH With Fatigue Symptoms.

NCT ID: NCT05194059

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-03

Study Completion Date

2022-10-28

Brief Summary

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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

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Conditions

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Hiv

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Home-based physical activity

Intervention Type BEHAVIORAL

Participants will follow a personalized activity pacing program

Control Group

Participants will follow a personalized activity pacing program for 16 weeks without any other support

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home-based physical activity

Participants will follow a personalized activity pacing program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Paola Cinque

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Infectious Diseases

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ActiPacMAN

Identifier Type: -

Identifier Source: org_study_id

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