Feasibility of Telerehabilitation in HIV-patients

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Behavioral: Endurance ad Resistance Training Exercise

• Registration Number: NCT03335176
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2015-04-01
• Study Completion: 2015-04-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-11-02
• Last Update Submitted: 2017-11-02
• Study First Posted: 2017-11-07
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endurance and Resistance Training Exercise	Endurance ad Resistance Training Exercise	-

Primary Outcome Measures

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

Secondary Outcome Measures

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