ClinicalTrials.gg
CompletedNCT03445351PLHAUpdated Feb 26, 2018

Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS

An interventional study of Aerobic, resistance and concorrent. in HIV/AIDS and Infections, Disorder Sleep and Lipodystrophy, sponsored by JULIANY DE SOUZA ARAUJO. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by JULIANY DE SOUZA ARAUJO · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 10 months after the study started (first participant enrolled Jan 2013, registered Nov 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • HIV/AIDS and Infections
  • Disorder Sleep
  • Lipodystrophy

Keywords

  • Exercise Therapy;
  • Sleep;
  • ; Immune Markers;
  • HIV
03

In context

Acquired Immunodeficiency Syndrome

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

This study's enrollment of 17 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

This is the only study on the registry with JULIANY DE SOUZA ARAUJO as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must have age ≥ 18 years old;
  • diagnosis of /AIDS;
  • use of antiretroviral therapy;
  • Must have lymphocyte T ≥ 350 cel/mm3
  • Must have physical fitness by the assistant physician.

Exclusion criteria

Exclusion Criteria:

  • pregnancy;
  • severe hearing deficiency.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    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.

    Other: Aerobic, resistance and concorrent.

Interventions

  • OtherAerobic, 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 24 MONTHS

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2013 to primary completion in Apr 2015, 27 months.

Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 27 months is close to that.

Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2017
First posted
Feb 26, 2018
StartActual
Jan 20, 2013
Primary completionActual
Apr 22, 2015
CompletionActual
Sep 13, 2016
Last update
Feb 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03445351
Lead sponsor
JULIANY DE SOUZA ARAUJO
Responsible party
JULIANY DE SOUZA ARAUJO (CLINICAL TEACHER, Universidade Federal do Rio Grande do Norte) — Sponsor-investigator
First posted
Feb 26, 2018
Start date
Jan 20, 2013
Primary completion
Apr 22, 2015
Completion
Sep 13, 2016
Last update
Feb 26, 2018

Study contacts

RAFAELA MEDEIROS
principal investigator · Universidade Federal do Rio Grande do Norte

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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