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Clinical Trials/NCT03335176
NCT03335176
Completed
N/A

Feasibility and Benefit of a Telerehabilitation Program in Human Immunodeficiency Virus-infected Patients

Cliniques universitaires Saint-Luc- Université Catholique de Louvain0 sites25 target enrollmentNovember 1, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Human Immunodeficiency Virus
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Enrollment
25
Primary Endpoint
Retention rate
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to assess the feasibility and the effects of a 6-week telerehabilitation on the three domains of the International Classification of Functioning, Disability and Health in HIV-infected patients under highly active antiretroviral therapy (HAART).

HIV-infected patients were randomized either into an Endurance and Resistance Training Exercise (ERTE) group or a control (CON) group. Telerehabilitation was realized in a public fitness center, with online guidance and weekly telephone advice, 3 times per week for 6 weeks. Feasibility was determined by recruitment rate, retention rate and adverse events. Secondary outcomes were impact on body composition, inflammation and coagulation (C-reactive protein, D-dimer), physical fitness and quality of life (WHOQOL-HIV).

Registry
clinicaltrials.gov
Start Date
November 1, 2014
End Date
April 1, 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible Party
Principal Investigator
Principal Investigator

Caty

Principal Investigator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • under HAART treatment
  • native French speaker

Exclusion Criteria

  • AIDS diagnosis
  • physical and/or psychiatric impairments that seriously impaired physical activity
  • Unstable (defined by any modification of health outcomes during the last 6 months).

Outcomes

Primary Outcomes

Retention rate

Time Frame: At study completion (after 6 weeks)

Percentage of patients lost to follow-up

Adverse events

Time Frame: At study completion (after 6 weeks)

Percentage of patients who experienced one or more adverse events

Recruitment rate

Time Frame: At study completion (after 6 weeks)

Number of eligible participants who enrolled in the program out of the number were recruited

Secondary Outcomes

  • Weight(Assessments at baseline and at 6 weeks)
  • D-dimer(Assessments at baseline and at 12 weeks)
  • Lean body mass(Assessments at baseline and at 6 weeks)
  • Fat body mass(Assessments at baseline and at 6 weeks)
  • C-reactive protein(Assessments at baseline and at 12 weeks)
  • CD4+ T cell counts(Assessments at baseline and at 12 weeks)
  • Viral load(Assessments at baseline and at 12 weeks)
  • Lower body muscular strength(Assessments at baseline and at 6 weeks)
  • Functional exercise capacity(Assessments at baseline and at 6 weeks)
  • Flexibility(Assessments at baseline and at 6 weeks)
  • Upper limb strength(Assessments at baseline and at 6 weeks)
  • Quality of life(Assessments at baseline and at 6 weeks)

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