Feasibility of Telerehabilitation in HIV-patients

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335176
• Other study ID #: Telerehabilitation HIV
• Status: Completed
• Phase: N/A
• First received: October 31, 2017
• Last updated: November 2, 2017
• Start date: November 1, 2014
• Est. completion date: April 1, 2015

Study information

• Verified date: October 2017
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 1, 2015
• Est. primary completion date: April 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• Endurance ad Resistance Training Exercise
Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of eligible participants who enrolled in the program out of the number were recruited	At study completion (after 6 weeks)
Primary	Retention rate	Percentage of patients lost to follow-up	At study completion (after 6 weeks)
Primary	Adverse events	Percentage of patients who experienced one or more adverse events	At study completion (after 6 weeks)
Secondary	Weight	Weight (kg) is measured by using a bioelectrical impedance analysis	Assessments at baseline and at 6 weeks
Secondary	Lean body mass	Lean body mass (kg) is measured by using a bioelectrical impedance analysis	Assessments at baseline and at 6 weeks
Secondary	Fat body mass	Lean body mass (kg) is measured by using a bioelectrical impedance analysis	Assessments at baseline and at 6 weeks
Secondary	C-reactive protein	C-reactive protein is measured by a blood test	Assessments at baseline and at 12 weeks
Secondary	D-dimer	D-dimer is measured by a blood test	Assessments at baseline and at 12 weeks
Secondary	CD4+ T cell counts	CD4+ T cell counts is measured by a blood test	Assessments at baseline and at 12 weeks
Secondary	Viral load	Viral load is measured by a blood test	Assessments at baseline and at 12 weeks
Secondary	Functional exercise capacity	Functional exercise capacity is measured by a 6-minute walk test	Assessments at baseline and at 6 weeks
Secondary	Flexibility	Flexibility is measured by Toe touch test and sit and reach test	Assessments at baseline and at 6 weeks
Secondary	Lower body muscular strength	Lower body muscular strength is measured by 30-s chair-stand test	Assessments at baseline and at 6 weeks
Secondary	Upper limb strength	Upper limb strength is measured by hand grip strength tool	Assessments at baseline and at 6 weeks
Secondary	Quality of life	Quality of life is measured by World Health Organization Quality of Life HIV Instrument	Assessments at baseline and at 6 weeks