---
title: Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
nct_id: NCT03445351
overall_status: COMPLETED
phase: NA
sponsor: JULIANY DE SOUZA ARAUJO
study_type: INTERVENTIONAL
primary_condition: HIV/AIDS and Infections
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03445351.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03445351"
ct_last_update_post_date: 2018-02-26
last_seen_at: "2026-05-12T06:24:07.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS

**Official Title:** Effect of Exercise on Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS

**NCT ID:** [NCT03445351](https://clinicaltrials.gov/study/NCT03445351)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 17
- **Lead Sponsor:** JULIANY DE SOUZA ARAUJO
- **Conditions:** HIV/AIDS and Infections, Disorder Sleep, Lipodystrophy
- **Start Date:** 2013-01-20
- **Completion Date:** 2016-09-13
- **CT.gov Last Update:** 2018-02-26

## Brief 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.

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **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:

* pregnancy;
* severe hearing deficiency.
```

## Arms

- **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.

## Interventions

- **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.

## Primary Outcomes

- **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.

## Secondary Outcomes

- **Quality of sleep** _(time frame: 24 MONTHS)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

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