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CompletedNCT05194059ActiPacMANUpdated Jan 18, 2023

'Activity Pacing' in PLWH With Fatigue Symptoms.

An interventional study of Home-based physical activity in Hiv, sponsored by Scientific Institute San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Scientific Institute San Raffaele · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Hiv

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03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 24 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Scientific Institute San Raffaele is the lead sponsor of 29 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • No intervention
    Control Group

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

Interventions

  • BehavioralHome-based physical activity

    Participants will follow a personalized activity pacing program

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What researchers measure

Primary outcomes

  1. Activity pacing improvement

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

    Time frame: 16 week

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Study locations

1 site
  • Department of Infectious Diseases
    Milan, 20127, Italy
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05194059
Lead sponsor
Scientific Institute San Raffaele
Responsible party
Paola Cinque (Principal Investigator, Scientific Institute San Raffaele) — Principal investigator
First posted
Jan 18, 2022
Start date
Dec 3, 2021
Primary completion
Oct 28, 2022
Completion
Oct 28, 2022
Last update
Jan 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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