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Feasibility of Telerehabilitation in HIV-patients

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ClinicalTrials.gov Identifier: NCT03335176
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Caty, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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).


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Endurance ad Resistance Training Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Benefit of a Telerehabilitation Program in Human Immunodeficiency Virus-infected Patients
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : April 1, 2015
Actual Study Completion Date : April 1, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endurance and Resistance Training Exercise Behavioral: Endurance ad Resistance Training Exercise
Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week

No Intervention: Control group
Usual care



Primary Outcome Measures :
  1. 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

  2. Retention rate [ Time Frame: At study completion (after 6 weeks) ]
    Percentage of patients lost to follow-up

  3. Adverse events [ Time Frame: At study completion (after 6 weeks) ]
    Percentage of patients who experienced one or more adverse events


Secondary Outcome Measures :
  1. Weight [ Time Frame: Assessments at baseline and at 6 weeks ]
    Weight (kg) is measured by using a bioelectrical impedance analysis

  2. Lean body mass [ Time Frame: Assessments at baseline and at 6 weeks ]
    Lean body mass (kg) is measured by using a bioelectrical impedance analysis

  3. Fat body mass [ Time Frame: Assessments at baseline and at 6 weeks ]
    Lean body mass (kg) is measured by using a bioelectrical impedance analysis

  4. C-reactive protein [ Time Frame: Assessments at baseline and at 12 weeks ]
    C-reactive protein is measured by a blood test

  5. D-dimer [ Time Frame: Assessments at baseline and at 12 weeks ]
    D-dimer is measured by a blood test

  6. CD4+ T cell counts [ Time Frame: Assessments at baseline and at 12 weeks ]
    CD4+ T cell counts is measured by a blood test

  7. Viral load [ Time Frame: Assessments at baseline and at 12 weeks ]
    Viral load is measured by a blood test

  8. Functional exercise capacity [ Time Frame: Assessments at baseline and at 6 weeks ]
    Functional exercise capacity is measured by a 6-minute walk test

  9. Flexibility [ Time Frame: Assessments at baseline and at 6 weeks ]
    Flexibility is measured by Toe touch test and sit and reach test

  10. Lower body muscular strength [ Time Frame: Assessments at baseline and at 6 weeks ]
    Lower body muscular strength is measured by 30-s chair-stand test

  11. Upper limb strength [ Time Frame: Assessments at baseline and at 6 weeks ]
    Upper limb strength is measured by hand grip strength tool

  12. Quality of life [ Time Frame: Assessments at baseline and at 6 weeks ]
    Quality of life is measured by World Health Organization Quality of Life HIV Instrument



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • pregnant
  • Unstable (defined by any modification of health outcomes during the last 6 months).
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Responsible Party: Caty, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03335176    
Other Study ID Numbers: Telerehabilitation HIV
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases