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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

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

Who can participate

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • pregnancy;
  • severe hearing deficiency.
04

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.

05

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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
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