Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201602001465776 Date of Approval: 08/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of aerobic exercise on the pulmonary functions, respiratory symptoms and psychological status of people living with HIV
Official scientific title Effects of aerobic exercise on the pulmonary functions, respiratory symptoms and psychological status of people living with HIV
Brief summary describing the background and objectives of the trial Pulmonary complications, respiratory symptoms and depression are common occurrences which contribute to the morbidity and mortality seen in individuals living with HIV/AIDS. This study investigated the effects of aerobic exercise on the pulmonary functions, respiratory symptoms and psychological status of people living with HIV.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 28/10/2014
Actual trial start date 28/10/2014
Anticipated date of last follow up 26/06/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 38
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ASSIGNED NO: ADM/DCST/HREC/2077 Lagos University Teaching Hospital Health Research and Ethics Commitee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised The randomization was done by simple random sampling using the fish bowl method where numbers one to forty were written on cards, then wrapped and put into a container. Numbers one to twenty represented the study group while numbers 21 to 40 represented the control group. Numbers one to forty were written on cards, then wrapped and put into a container. They were thoroughly mixed together and subjects picked from it. Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aerobic exercise 3 times a week for 6 weeks 30 minutes per session Participants underwent aerobic exercise using bicycle ergometer 20
Control Group Counselling sessions Once a week 30 minutes per session Subjects in this group had interactive counselling sessions on the importance of physical activity and were allowed to ask questions concerning the way they were feeling. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This study involved people living with HIV who are: 1. 18 years and above 2. On current use of Highly Active Anti Retroviral Therapy (HAART). 3. Have met Centres for Disease Control and Prevention (CDC) classifications A2 (Asymptomatic, non-AIDS) or B2 (Symptomatic, non-AIDS) (CDC, 1993) ascertained from the patients¿ medical records. 4. Available to participate in the study 1. Pregnant women 2. Individuals whose medical history showed current active opportunistic infections (such as Tuberculosis) 3. Individuals with a history of cardiovascular disease and symptoms of cardiovascular disease (screened using American Heart Association- American College of Sports Medicine Participation Screening Questionnaire) 4. Significant cognitive impairment or inability to follow instructions 5. Involvement in a regular exercise programme (defined as two or more structured exercise sessions weekly for more than or equal to six weeks prior to enrolment). This was ascertained by interview. 18 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/10/2014 Lagos UniversitynTeaching Hospital Health Research and Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Lagos University Teaching Hospital compound, Idi-Araba, Lagos Lagos 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pulmonary function parameters such as Forced vital capacity (FVC), Forced expiratory volume in 1 sec (FEV1), Peak flow rate and Respiratory rate) 1. At baseline before intervetion started 2. At endpoint after 6 weeks of intervention
Primary Outcome Respiratory symptoms such as wheeze, productive cough etc 1, At baseline before intervention started 2. At endpoint after 6 weeks intervention
Secondary Outcome Depression status 1, At baseline before intervention started 2. At endpoint after 6 weeks intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out patient Clinic, Lagos state University Teaching Hospital Ikeja Lagos 234 Nigeria
AIDS prevention Initiative (APIN) Clinic, Lagos University Teaching Hospital, Idi-Araba Lagos 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
NONE
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Lagos Idi-Araba Lagos 234 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
NONE
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Happiness Aweto awetohappiness@gmail.com +2348028964385 Department of Physiotherapy, College of Medicine, Idi-Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Ayoola Aiyegbusi aaiyegbusi@unilag.edu.ng +2348184078287 Department of Physiotherapy, College of Medicine, Idi-Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Senior Lectuer
Role Name Email Phone Street address
Scientific Enquiries Adaora Ugonabo talk2doragreen@yahoo.com +2349096017960 Department of Physiotherapy, College of Medicine, Idi-Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Titilope Adeyemo titilopeadeyemo2002@yahoo.uk.c0 +2348023208590 Department of Haematology and Blood transfusion, College of Medicine, Idi-Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Lecturer/Consultant to Lagos University Teaching Hospital
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information