'Activity Pacing' in PLWH With Fatigue Symptoms.

NCT05194059 | Completed

• 1 other identifier: ActiPacMAN
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• Activity pacing improvement

  To compare the improvement in the physical fitness between the Experimental Group and Control Group

  16 week

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Home-based physical activity BEHAVIORAL

Participants will follow a personalized activity pacing program

Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

Department of Infectious Diseases

Milan, 20127, Italy

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: December 3, 2021
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)