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

Not Applicable

Completed

• Conditions: Disorder Sleep; Lipodystrophy; HIV/AIDS and Infections
• Interventions: Other: Aerobic, resistance and concorrent.

• Registration Number: NCT03445351
• Lead Sponsor: JULIANY DE SOUZA ARAUJO

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).

Study Timeline

• Study Start: 2013-01-20
• Primary Completion: 2015-04-22
• Study Completion: 2016-09-13
• Study First Submitted: 2017-11-21
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-19
• Last Update Submitted: 2018-02-19
• Study First Posted: 2018-02-26
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aerobic, resistance and concorrent	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.