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

Lipodystrophy Clinical Trial

— PLHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445351
• Other study ID #: AFISA
• Status: Completed
• Phase: N/A
• First received: November 21, 2017
• Last updated: February 19, 2018
• Start date: January 20, 2013
• Est. completion date: September 13, 2016

Study information

• Verified date: February 2018
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 13, 2016
• Est. primary completion date: April 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disorder Sleep
• HIV/AIDS and Infections
• Lipodystrophy
• Parasomnias
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JULIANY DE SOUZA ARAUJO

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 MONTHS
Secondary	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.	24 MONTHS