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

Sponsor
JULIANY DE SOUZA ARAUJO (Other)
Overall Status
Completed
CT.gov ID
NCT03445351
Collaborator
(none)
17
1
43.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aerobic, resistance and concorrent.
N/A

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

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Intervention study, prospective, a cohort with 17 PLHA participants of the exercise programIntervention study, prospective, a cohort with 17 PLHA participants of the exercise program
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Exercise on Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
Actual Study Start Date :
Jan 20, 2013
Actual Primary Completion Date :
Apr 22, 2015
Actual Study Completion Date :
Sep 13, 2016

Arms and Interventions

Arm Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

  1. Quality of life [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 Outcome Measures

  1. Quality of sleep [24 MONTHS]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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:
  • pregnancy;

  • severe hearing deficiency.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • JULIANY DE SOUZA ARAUJO

Investigators

  • Principal Investigator: RAFAELA MEDEIROS, Universidade Federal do Rio Grande do Norte

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
JULIANY DE SOUZA ARAUJO, CLINICAL TEACHER, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier:
NCT03445351
Other Study ID Numbers:
  • AFISA
First Posted:
Feb 26, 2018
Last Update Posted:
Feb 26, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by JULIANY DE SOUZA ARAUJO, CLINICAL TEACHER, Universidade Federal do Rio Grande do Norte
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2018