Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000683033
Ethics application status
Approved
Date submitted
7/08/2010
Date registered
19/08/2010
Date last updated
19/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a supervised exercise program on the physical fitness, immunological function and quality of life of Human immunodeficiency virus (HIV)-Infected Patients.
Scientific title
Effects of a supervised exercise program on the physical fitness, immunological function and quality of life of Human immunodeficiency virus (HIV)-Infected Patients.
Secondary ID [1] 252393 0
None
Universal Trial Number (UTN)
U1111-1116-4416
Trial acronym
ExHIV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) 257904 0
Condition category
Condition code
Infection 258067 258067 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant trained three times per week for 12 weeks in 90-min sessions that included aerobic, resistance and flexibility exercises. Aerobic training was performed on a cyclo-ergometer for 30 min at a moderate intensity (workload associated with 150 bpm - Physical Work Capacity 150) to avoid possible exercise-induced immunodepression. Baseline strength was assessed using 12 repetition maximum (12 RM) tests performed twice on nonconsecutive days in order to account for learning effects. The 12 RM test results were used to determine the resistances used in training. In the first week of training 3 sets of 12 repetitions at 60% of 12 RM were performed in all exercises. During the remaining weeks the workload was 80% of 12 RM. The program included the following exercises: leg press, bench press, knee extension, seated bilateral row and abdominal sit-ups, with rest intervals of 2-3 min between sets and exercises. The exercises were supervised by exercise specialists on a one-to-one basis or in small groups (2–3 subjects at a time). At the end of the sessions a 10-min flexibility routine was performed involving all the major joints, using static stretching (2 sets of each exercise, holding the maximal range of motion for 30-s).
Intervention code [1] 256958 0
Lifestyle
Intervention code [2] 256975 0
Other interventions
Comparator / control treatment
Active control, HIV-infected patients which did not underwent the exercise training.
Control group
Active

Outcomes
Primary outcome [1] 258931 0
Fitness indicators. Submaximal aerobic capacity was assessed by a 3-stage cycle ergometer protocol (5-min each stage, 25W, 35W, and 40W). Individual regression equations were calculated for the relationship between heart rate (HR) and workload (W). The mean values for the slopes and intercepts obtained prior and after the training protocol were then compared between and within groups. Strength was assessed by 12 RM tests for all exercises in the training program at baseline and for the leg press and seated bilateral row at the end of the exercise program. Hip and leg flexibility were assessed by the sit-and-reach test. To perform this test the subject was seated on the floor with knees straight, feet placed firmly against a transportable reach bench of 45 cm length and 35 cm width). Arms and trunk were bent forward with the hands placed on the vertical scale attached to the upper surface of the bench. Subjects then bent forward at the waist as far as possible. Four attempts were allowed and the best result was recorded.
Timepoint [1] 258931 0
at baseline and at 6, 12, 18, 24 weeks after intervention commencement
Primary outcome [2] 258948 0
TCD4 cells. In order to determine the CD4 T-cell absolute and relative count, a sample of blood (450microliters) was collected in EDTA vacutainer tubes (Becton-Dickinson (trademark-TM), San Jose, CA, USA). The fresh peripheral venous blood was collected and direct immunofluorescence was measured by flow cytometry [Becton Dickinson (TM) FACScan, San Jose, CA, USA].
Timepoint [2] 258948 0
at baseline and at 6, 12, 18, 24 weeks after intervention commencement
Primary outcome [3] 258949 0
quality of life indicators, measured by the Life Satisfaction Index and World Health Organization Quality of Life Questionnaire.
Timepoint [3] 258949 0
at baseline and at 6, 12, 18, 24 weeks after intervention commencement
Secondary outcome [1] 265099 0
All-cause mortality at 1 year and 3 years assessed by patient medical records consultation.
Timepoint [1] 265099 0
At 1 year and 3 years after commencement.

Eligibility
Key inclusion criteria
Seropositive patients treated with highly active antiretroviral therapy (HAART) for at least six months.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smoking tobacco, changes in antiretroviral medication during the experimental protocol, participation in exercise training in the previous six months and medical contraindication to exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Seropositive patients treated with HAART for at least six months were recruited for the study and randomly assigned to either an experimental or control group (simple randomisation by coin-tossing. The number of subjects assigned to the experimental group was higher than that assigned to the control group to maintain a high number of training subjects even if adherence to the training program was low.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2808 0
Brazil
State/province [1] 2808 0
RJ

Funding & Sponsors
Funding source category [1] 257413 0
Government body
Name [1] 257413 0
Brazilian Council for the Technological and Research Development (CNPq)
Country [1] 257413 0
Brazil
Primary sponsor type
University
Name
State University of Rio de Janeiro
Address
Rua Sao Francisco Xavier 524, Maracana, Rio de Janeiro, RJ, Brasil. CEP 20550-013
Country
Brazil
Secondary sponsor category [1] 256644 0
Hospital
Name [1] 256644 0
Pedro Ernesto University Hospital
Address [1] 256644 0
Boulevard 28 de setembro, 77 - Vila Isabel - Cep 20.551-030 - Rio de Janeiro - RJ - Brasil
Country [1] 256644 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259437 0
State University of Rio de Janeiro Ethics Committee
Ethics committee address [1] 259437 0
Ethics committee country [1] 259437 0
Brazil
Date submitted for ethics approval [1] 259437 0
12/01/2008
Approval date [1] 259437 0
10/03/2008
Ethics approval number [1] 259437 0
1942-CEP/HUPE

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31488 0
Address 31488 0
Country 31488 0
Phone 31488 0
Fax 31488 0
Email 31488 0
Contact person for public queries
Name 14735 0
Paulo Farinatti
Address 14735 0
Phyisical Activity and Health Promotion Laboratory, State University of Rio de Janeiro, Rua Sao Francisco Xavier 524/sala 8121F, Rio de Janeiro, Brazil, CEP 20550-013
Country 14735 0
Brazil
Phone 14735 0
+55-21-23340775
Fax 14735 0
Email 14735 0
[email protected]
Contact person for scientific queries
Name 5663 0
Paulo Farinatti
Address 5663 0
Physical Activity and Health Promotion Laboratory, State University of Rio de Janeiro, Rua Sao Francisco Xavier 524/sala 8121F, Rio de Janeiro, Brazil, CEP 20550-013
Country 5663 0
Brazil
Phone 5663 0
+55-21-23340775
Fax 5663 0
Email 5663 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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