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CompletedNCT03335176Updated Nov 7, 2017

Feasibility of Telerehabilitation in HIV-patients

An interventional study of Endurance ad Resistance Training Exercise in Human Immunodeficiency Virus, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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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Study design

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

Study arms

  • Experimental
    Endurance and Resistance Training Exercise

    Behavioral: Endurance ad Resistance Training Exercise

  • No intervention
    Control group

    Usual care

Interventions

  • BehavioralEndurance ad Resistance Training Exercise

    Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week

05

What researchers measure

Primary outcomes

  1. Recruitment rate

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

    Time frame: At study completion (after 6 weeks)

  2. Retention rate

    Percentage of patients lost to follow-up

    Time frame: At study completion (after 6 weeks)

  3. Adverse events

    Percentage of patients who experienced one or more adverse events

    Time frame: At study completion (after 6 weeks)

Secondary outcomes

  1. Weight

    Weight (kg) is measured by using a bioelectrical impedance analysis

    Time frame: Assessments at baseline and at 6 weeks

  2. Lean body mass

    Lean body mass (kg) is measured by using a bioelectrical impedance analysis

    Time frame: Assessments at baseline and at 6 weeks

  3. Fat body mass

    Lean body mass (kg) is measured by using a bioelectrical impedance analysis

    Time frame: Assessments at baseline and at 6 weeks

  4. C-reactive protein

    C-reactive protein is measured by a blood test

    Time frame: Assessments at baseline and at 12 weeks

  5. D-dimer

    D-dimer is measured by a blood test

    Time frame: Assessments at baseline and at 12 weeks

  6. CD4+ T cell counts

    CD4+ T cell counts is measured by a blood test

    Time frame: Assessments at baseline and at 12 weeks

  7. Viral load

    Viral load is measured by a blood test

    Time frame: Assessments at baseline and at 12 weeks

  8. Functional exercise capacity

    Functional exercise capacity is measured by a 6-minute walk test

    Time frame: Assessments at baseline and at 6 weeks

  9. Flexibility

    Flexibility is measured by Toe touch test and sit and reach test

    Time frame: Assessments at baseline and at 6 weeks

  10. Lower body muscular strength

    Lower body muscular strength is measured by 30-s chair-stand test

    Time frame: Assessments at baseline and at 6 weeks

  11. Upper limb strength

    Upper limb strength is measured by hand grip strength tool

    Time frame: Assessments at baseline and at 6 weeks

  12. Quality of life

    Quality of life is measured by World Health Organization Quality of Life HIV Instrument

    Time frame: Assessments at baseline and at 6 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03335176
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Caty (Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain) — Principal investigator
First posted
Nov 7, 2017
Start date
Nov 1, 2014
Primary completion
Apr 1, 2015
Completion
Apr 1, 2015
Last update
Nov 7, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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