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Feasibility of Telerehabilitation in HIV-patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03335176
Enrollment
25
Registered
2017-11-07
Start date
2014-11-01
Completion date
2015-04-01
Last updated
2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus

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).

Interventions

BEHAVIORALEndurance ad Resistance Training Exercise

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

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rateAt study completion (after 6 weeks)Number of eligible participants who enrolled in the program out of the number were recruited
Retention rateAt study completion (after 6 weeks)Percentage of patients lost to follow-up
Adverse eventsAt study completion (after 6 weeks)Percentage of patients who experienced one or more adverse events

Secondary

MeasureTime frameDescription
C-reactive proteinAssessments at baseline and at 12 weeksC-reactive protein is measured by a blood test
D-dimerAssessments at baseline and at 12 weeksD-dimer is measured by a blood test
CD4+ T cell countsAssessments at baseline and at 12 weeksCD4+ T cell counts is measured by a blood test
Viral loadAssessments at baseline and at 12 weeksViral load is measured by a blood test
WeightAssessments at baseline and at 6 weeksWeight (kg) is measured by using a bioelectrical impedance analysis
FlexibilityAssessments at baseline and at 6 weeksFlexibility is measured by Toe touch test and sit and reach test
Lower body muscular strengthAssessments at baseline and at 6 weeksLower body muscular strength is measured by 30-s chair-stand test
Upper limb strengthAssessments at baseline and at 6 weeksUpper limb strength is measured by hand grip strength tool
Quality of lifeAssessments at baseline and at 6 weeksQuality of life is measured by World Health Organization Quality of Life HIV Instrument
Functional exercise capacityAssessments at baseline and at 6 weeksFunctional exercise capacity is measured by a 6-minute walk test
Lean body massAssessments at baseline and at 6 weeksLean body mass (kg) is measured by using a bioelectrical impedance analysis
Fat body massAssessments at baseline and at 6 weeksLean body mass (kg) is measured by using a bioelectrical impedance analysis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026