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
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
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
NCT ID
NCT03445351
First Posted
November 21, 2017
Last Updated
February 19, 2018
Sponsor
JULIANY DE SOUZA ARAUJO
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
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Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
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