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

NCT03445351 | Completed

• 1 other identifier: AFISA
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV/AIDS and Infections; Disorder Sleep; Lipodystrophy

Keywords

Exercise Therapy;; Sleep;; ; Immune Markers;; HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of sleep

  24 MONTHS

Study Arms (1)

Aerobic, resistance and concorrent

EXPERIMENTAL

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.

Interventions

Aerobic, resistance and concorrent. OTHER

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.

Aerobic, resistance and concorrent

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• pregnancy;
• severe hearing deficiency.

Sponsors & Collaborators

• JULIANY DE SOUZA ARAUJO: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections; Parasomnias; Lipodystrophy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• RAFAELA MEDEIROS

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CLINICAL TEACHER

Model Details: Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: February 26, 2018
• Study Start: January 20, 2013
• Primary Completion: April 22, 2015
• Study Completion: September 13, 2016
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share