Feasibility of Telerehabilitation in HIV-patients

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

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: Endurance ad Resistance Training Exercise

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: Telerehabilitation HIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No