'Activity Pacing' in PLWH With Fatigue Symptoms.

Hiv Clinical Trial

— ActiPacMAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194059
• Other study ID #: ActiPacMAN
• Status: Completed
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: January 2023
• Source: Scientific Institute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fatigue
• Hiv

Intervention

Behavioral:
• Home-based physical activity
Participants will follow a personalized activity pacing program

Locations

Country	Name	City	State
Italy	Department of Infectious Diseases	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity pacing improvement	To compare the improvement in the physical fitness between the Experimental Group and Control Group	16 week