Skip to main content
OpenTrials
Completed

NCT Number: NCT03335176

Feasibility of Telerehabilitation in HIV-patients

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Endurance ad Resistance Training Exercise

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2017
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.