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Clinical Trials/NCT03445351
NCT03445351
Completed
Not Applicable

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

JULIANY DE SOUZA ARAUJO0 sites17 target enrollmentJanuary 20, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS and Infections
Sponsor
JULIANY DE SOUZA ARAUJO
Enrollment
17
Primary Endpoint
Quality of life
Status
Completed
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 20, 2013
End Date
September 13, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
JULIANY DE SOUZA ARAUJO
Responsible Party
Sponsor Investigator
Principal Investigator

JULIANY DE SOUZA ARAUJO

CLINICAL TEACHER

Universidade Federal do Rio Grande do Norte

Eligibility Criteria

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.

Outcomes

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(24 MONTHS)

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