Human Immunodeficiency VirusNCT03335176
Feasibility of Telerehabilitation in HIV-patients
A study testing Endurance ad Resistance Training Exercise in people with Human Immunodeficiency Virus, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Endurance ad Resistance Training Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 1 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- under HAART treatment
- native French speaker
Who cannot join
- 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).
About this study
Official title: 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).
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Endurance ad Resistance Training Exercise
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance ad Resistance Training ExerciseBehavioural
Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week
| Study group | Role | What they receive |
|---|---|---|
| Endurance and Resistance Training Exercise | Experimental | Not described Receives: Behavioral: Endurance ad Resistance Training Exercise |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of eligible participants who enrolled in the program out of the number were recruited
Measured: At study completion (after 6 weeks)
Retention rate
Percentage of patients lost to follow-up
Measured: At study completion (after 6 weeks)
Adverse events
Percentage of patients who experienced one or more adverse events
Measured: At study completion (after 6 weeks)
Secondary outcomes (12)
Weight
Weight (kg) is measured by using a bioelectrical impedance analysis
Measured: Assessments at baseline and at 6 weeks
Lean body mass
Lean body mass (kg) is measured by using a bioelectrical impedance analysis
Measured: Assessments at baseline and at 6 weeks
Fat body mass
Lean body mass (kg) is measured by using a bioelectrical impedance analysis
Measured: Assessments at baseline and at 6 weeks
C-reactive protein
C-reactive protein is measured by a blood test
Measured: Assessments at baseline and at 12 weeks
D-dimer
D-dimer is measured by a blood test
Measured: Assessments at baseline and at 12 weeks
CD4+ T cell counts
CD4+ T cell counts is measured by a blood test
Measured: Assessments at baseline and at 12 weeks
Viral load
Viral load is measured by a blood test
Measured: Assessments at baseline and at 12 weeks
Functional exercise capacity
Functional exercise capacity is measured by a 6-minute walk test
Measured: Assessments at baseline and at 6 weeks
Flexibility
Flexibility is measured by Toe touch test and sit and reach test
Measured: Assessments at baseline and at 6 weeks
Lower body muscular strength
Lower body muscular strength is measured by 30-s chair-stand test
Measured: Assessments at baseline and at 6 weeks
Upper limb strength
Upper limb strength is measured by hand grip strength tool
Measured: Assessments at baseline and at 6 weeks
Quality of life
Quality of life is measured by World Health Organization Quality of Life HIV Instrument
Measured: Assessments at baseline and at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Nov 2014
- Primary completion1 Apr 2015
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caty, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335176
- Sponsor's protocol ID
- Telerehabilitation HIV
- Status last verified
- Oct 2017
- First submitted
- 31 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Benefit of a Telerehabilitation Program in Human Immunodeficiency Virus-infected Patients
- ClinicalTrials.gov ID
- NCT03335176
- Acronym / sponsor ID
- Telerehabilitation HIV
- Conditions
- Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance and Resistance Training Exercise | Experimental | Behavioral: Endurance ad Resistance Training Exercise |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- under HAART treatment
- native French speaker
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance ad Resistance Training ExercisePatients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week | Behavioural | Endurance and Resistance Training Exercise |
Primary outcome
Recruitment rate
Time frame: At study completion (after 6 weeks)
Number of eligible participants who enrolled in the program out of the number were recruited
Retention rate
Time frame: At study completion (after 6 weeks)
Percentage of patients lost to follow-up
Adverse events
Time frame: At study completion (after 6 weeks)
Percentage of patients who experienced one or more adverse events
12 secondary outcomes
Weight
Time frame: Assessments at baseline and at 6 weeks
Lean body mass
Time frame: Assessments at baseline and at 6 weeks
Fat body mass
Time frame: Assessments at baseline and at 6 weeks
C-reactive protein
Time frame: Assessments at baseline and at 12 weeks
D-dimer
Time frame: Assessments at baseline and at 12 weeks
CD4+ T cell counts
Time frame: Assessments at baseline and at 12 weeks
Viral load
Time frame: Assessments at baseline and at 12 weeks
Functional exercise capacity
Time frame: Assessments at baseline and at 6 weeks
Flexibility
Time frame: Assessments at baseline and at 6 weeks
Lower body muscular strength
Time frame: Assessments at baseline and at 6 weeks
Upper limb strength
Time frame: Assessments at baseline and at 6 weeks
Quality of life
Time frame: Assessments at baseline and at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance ad Resistance Training Exercise in people with Human Immunodeficiency Virus, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: At study completion (after 6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.