Feasibility of Telerehabilitation in HIV-patients

NCT03335176 | Completed

• 1 other identifier: Telerehabilitation HIV
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Weight

  Assessments at baseline and at 6 weeks

• Lean body mass

  Assessments at baseline and at 6 weeks

• Fat body mass

  Assessments at baseline and at 6 weeks

• C-reactive protein

  Assessments at baseline and at 12 weeks

• D-dimer

  Assessments at baseline and at 12 weeks

Study Arms (2)

Endurance and Resistance Training Exercise

EXPERIMENTAL

Behavioral: Endurance ad Resistance Training Exercise

Control group

NO INTERVENTION

Usual care

Interventions

Endurance ad Resistance Training Exercise BEHAVIORAL

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

Endurance and Resistance Training Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• under HAART treatment
• native French speaker

You may not qualify if:

• 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).

Sponsors & Collaborators

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

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 7, 2017
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 7, 2017

Record last verified: 2017-10