HIV/AIDS and InfectionsPLHANCT03445351
Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
A study testing Aerobic, resistance and concorrent. in people with HIV/AIDS and Infections and Disorder Sleep, run by JULIANY DE SOUZA ARAUJO.
Trial summary
Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study, prospective. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV/AIDS and Infections, Disorder Sleep, Lipodystrophy
- What is being tested?
- Aerobic, resistance and concorrent.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2013to 13 Sep 2016
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must have age ≥ 18 years old;
- diagnosis of HIV/AIDS;
- use of antiretroviral therapy;
- Must have lymphocyte T CD4+ cell count ≥ 350 cel/mm3
- Must have physical fitness by the assistant physician.
Who cannot join
- pregnancy;
- severe hearing deficiency.
About this study
Official title: Effect of Exercise on Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study, prospective.
Read the detailed description
Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program, higher than 18 years, under antiretroviral therapy with CD4+ ≥ 350/mm3. Research Ethical Committee of the institution approved the study and the participants sign the informed consent and informed. All subjects underwent an exercise program in conformity to American College of Sports Medicine, 3 times per week during 40 minutes. Were evaluated the quality of life (QoL) with the Quality of Life - HAT - QoL and the sleep quality (SQ) with the Pittsburg questionnaire. The subjects were evaluated before the start of exercise program and in three times: short-term (2 to 4 months), medium-term (between 5 and 17 months) and long-term (between 18 to 25 months).
- Conditions
- HIV/AIDS and Infections, Disorder Sleep, Lipodystrophy
- Being tested
- Aerobic, resistance and concorrent.
- Keywords
- Exercise Therapy;, Sleep;, ; Immune Markers;, HIV
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections, Parasomnias, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic, resistance and concorrent.Other
All protocols followed the American College of Sports Medicine (ACSM) guidelines , with frequency of three times per week, duration between 40-50 minutes, low to high intensity, modified according to the physical needs of each participant, respecting the physical training principles.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic, resistance and concorrent | Experimental | The group underwent exercise program with protocols of resistance training, aerobic training and concurrent training, with frequency of three times per week. Receives: Other: Aerobic, resistance and concorrent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
A translation adapted and validated for Brazil of the HIV/AIDS Targeted Quality of Life questionnaire (HAT-QoL) developed by Holmes \& Shea, was used . The HAT-QoL present 34 questions divided in nine domains: Overall Function (OVEFUN), Life Satisfaction (LISA), Health Worries (HEAWOR), Financial Worries (FINWOR), Medication Concerns (MEDCON), HIV Mastery (HIVMAS), Disclosure Worries (DISWOR), Provider Trust (PROTRU) and Sexual Function (SEXFUN). The score ranges from 0 to 100. The responses have a five-point Likert scale: "all the time", "most of the time", "part of the time", "little time" and "never". In each domain, zero is the lowest score and 100 the best score possible. The higher the score, the lower the impact of HIV infection on the individuals' quality of life.
Measured: 24 MONTHS
Secondary outcomes (1)
Quality of sleep
For the QoS the Pittsburgh Sleep Quality Index validated for Brazilian population, was applied. This scale is composed of 19 items that evaluate aspects related to sleep latency, duration, usual efficiency, sleep disturbance, use of hypnotic drugs and daytime dysfunction in the last month. Scores smaller than 5 define good sleep quality; values ranging between 6 to 11 bad sleep quality and values greater than 11 sleep disturbance. To answer the questionnaires, the subjects were oriented to think about the QoL and QoS in the previous four weeks.
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start20 Jan 2013
- Primary completion22 Apr 2015
- Study completion13 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDS and InfectionsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- JULIANY DE SOUZA ARAUJO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JULIANY DE SOUZA ARAUJO, Universidade Federal do Rio Grande do Norte
- Investigators
- RAFAELA MEDEIROS, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445351
- Sponsor's protocol ID
- AFISA
- Acronym
- PLHA
- Status last verified
- Feb 2018
- First submitted
- 21 Nov 2017
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
- ClinicalTrials.gov ID
- NCT03445351
- Acronym / sponsor ID
- PLHA / AFISA
- Conditions
- HIV/AIDS and Infections, Disorder Sleep, Lipodystrophy
- Keywords
- Exercise Therapy;, Sleep;, ; Immune Markers;, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- JULIANY DE SOUZA ARAUJOUniversity, hospital or other
- Study start
- 20 Jan 2013 (actual)
- Primary completion
- 22 Apr 2015 (actual)
- Study completion
- 13 Sep 2016 (actual)
- First posted
- 26 Feb 2018 (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.
Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study, prospective.
Detailed description
Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program, higher than 18 years, under antiretroviral therapy with CD4+ ≥ 350/mm3. Research Ethical Committee of the institution approved the study and the participants sign the informed consent and informed. All subjects underwent an exercise program in conformity to American College of Sports Medicine, 3 times per week during 40 minutes. Were evaluated the quality of life (QoL) with the Quality of Life - HAT - QoL and the sleep quality (SQ) with the Pittsburg questionnaire. The subjects were evaluated before the start of exercise program and in three times: short-term (2 to 4 months), medium-term (between 5 and 17 months) and long-term (between 18 to 25 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program
| Arm | Type | Receives |
|---|---|---|
| Aerobic, resistance and concorrent | Experimental | Other: Aerobic, resistance and concorrent.The group underwent exercise program with protocols of resistance training, aerobic training and concurrent training, with frequency of three times per week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must have age ≥ 18 years old;
- diagnosis of HIV/AIDS;
- use of antiretroviral therapy;
- Must have lymphocyte T CD4+ cell count ≥ 350 cel/mm3
- Must have physical fitness by the assistant physician.
Key exclusion criteria (2 listed)
- pregnancy;
- severe hearing deficiency.
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 |
|---|---|---|
| Aerobic, resistance and concorrent.All protocols followed the American College of Sports Medicine (ACSM) guidelines , with frequency of three times per week, duration between 40-50 minutes, low to high intensity, modified according to the physical needs of each participant, respecting the physical training principles. | Other | Aerobic, resistance and concorrent |
Primary outcome
Quality of life
Time frame: 24 MONTHS
A translation adapted and validated for Brazil of the HIV/AIDS Targeted Quality of Life questionnaire (HAT-QoL) developed by Holmes \& Shea, was used . The HAT-QoL present 34 questions divided in nine domains: Overall Function (OVEFUN), Life Satisfaction (LISA), Health Worries (HEAWOR), Financial Worries (FINWOR), Medication Concerns (MEDCON), HIV Mastery (HIVMAS), Disclosure Worries (DISWOR), Provider Trust (PROTRU) and Sexual Function (SEXFUN). The score ranges from 0 to 100. The responses have a five-point Likert scale: "all the time", "most of the time", "part of the time", "little time" and "never". In each domain, zero is the lowest score and 100 the best score possible. The higher the score, the lower the impact of HIV infection on the individuals' quality of life.
1 secondary outcome
Quality of sleep
Time frame: 24 MONTHS
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 26 Feb 2018.
- Individual participant dataSharing planned: No
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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.
RAFAELA MEDEIROS principal investigator
Universidade Federal do Rio Grande do Norte
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic, resistance and concorrent. in people with HIV/AIDS and Infections and Disorder Sleep, run by JULIANY DE SOUZA ARAUJO.
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 5 inclusion and 2 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 26 Feb 2018. 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?
Quality of life (time frame: 24 MONTHS). 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 26 Feb 2018.