Feasibility of Telerehabilitation in HIV-patients

Study Overview
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Brief Summary
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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).

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

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: Endurance ad Resistance Training Exercise


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endurance and Resistance Training Exercise<br> | Behavioral: Endurance ad Resistance Training Exercise<br>* Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week<br>|
| No Intervention: Control group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Number of eligible participants who enrolled in the program out of the number were recruited | At study completion (after 6 weeks) | 
| Retention rate | Percentage of patients lost to follow-up | At study completion (after 6 weeks) | 
| Adverse events | Percentage of patients who experienced one or more adverse events | At study completion (after 6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight (kg) is measured by using a bioelectrical impedance analysis | Assessments at baseline and at 6 weeks | 
| Lean body mass | Lean body mass (kg) is measured by using a bioelectrical impedance analysis | Assessments at baseline and at 6 weeks | 
| Fat body mass | Lean body mass (kg) is measured by using a bioelectrical impedance analysis | Assessments at baseline and at 6 weeks | 
| C-reactive protein | C-reactive protein is measured by a blood test | Assessments at baseline and at 12 weeks | 
| D-dimer | D-dimer is measured by a blood test | Assessments at baseline and at 12 weeks | 
| CD4+ T cell counts | CD4+ T cell counts is measured by a blood test | Assessments at baseline and at 12 weeks | 
| Viral load | Viral load is measured by a blood test | Assessments at baseline and at 12 weeks | 
| Functional exercise capacity | Functional exercise capacity is measured by a 6-minute walk test | Assessments at baseline and at 6 weeks | 
| Flexibility | Flexibility is measured by Toe touch test and sit and reach test | Assessments at baseline and at 6 weeks | 
| Lower body muscular strength | Lower body muscular strength is measured by 30-s chair-stand test | Assessments at baseline and at 6 weeks | 
| Upper limb strength | Upper limb strength is measured by hand grip strength tool | Assessments at baseline and at 6 weeks | 
| Quality of life | Quality of life is measured by World Health Organization Quality of Life HIV Instrument | Assessments at baseline and at 6 weeks |