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

Primary Purpose

HIV/AIDS and Infections, Disorder Sleep, Lipodystrophy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic, resistance and concorrent.
Sponsored by
JULIANY DE SOUZA ARAUJO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS and Infections focused on measuring Exercise Therapy;, Sleep;, ; Immune Markers;, HIV

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Aerobic, resistance and concorrent

    Arm Description

    The group underwent exercise program with protocols of resistance training, aerobic training and concurrent training, with frequency of three times per week.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    November 21, 2017
    Last Updated
    February 19, 2018
    Sponsor
    JULIANY DE SOUZA ARAUJO
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03445351
    Brief Title
    Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
    Acronym
    PLHA
    Official Title
    Effect of Exercise on Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 20, 2013 (Actual)
    Primary Completion Date
    April 22, 2015 (Actual)
    Study Completion Date
    September 13, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    JULIANY DE SOUZA ARAUJO

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV/AIDS and Infections, Disorder Sleep, Lipodystrophy
    Keywords
    Exercise Therapy;, Sleep;, ; Immune Markers;, HIV

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Aerobic, resistance and concorrent
    Arm Type
    Experimental
    Arm Description
    The group underwent exercise program with protocols of resistance training, aerobic training and concurrent training, with frequency of three times per week.
    Intervention Type
    Other
    Intervention Name(s)
    Aerobic, resistance and concorrent.
    Intervention Description
    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 Outcome Measure Information:
    Title
    Quality of life
    Description
    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 Outcome Measure Information:
    Title
    Quality of sleep
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    RAFAELA MEDEIROS
    Organizational Affiliation
    Universidade Federal do Rio Grande do Norte
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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