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.: PACTR201711002709233 Date of Approval: 20/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of aerobic exercise on ovulatory function and quality of life among women with anovulatory infertility
Official scientific title Effect of aerobic exercise on ovulatory function and quality of life among women with anovulatory infertility
Brief summary describing the background and objectives of the trial Infertility is a global health issue with growing problems across cultures and societies. The incidence of infertility is highest in Africa with about 25% of Nigerian couples being infertile. Studies have recommend the use of aerobic exercise (EX) in anovulatory infertile women but there is inconsistency in the intensity, frequency and outcome. This study will determine the effect of EX on ovulatory function (ovulation, regularity of period, progesterone level) and quality of life (QOL) among women having anovulatory infertility. This study will be a randomized controlled trial (RCT). The population for this study will comprise of anovulatory infertility patients receiving treatment at Aminu Kano Teaching Hospital, Kano and Murtala Muhammad Specialist Hospital, Kano. Consenting participants will be recruited consecutively and randomly assigned to 2 groups using sealed opaque envelopes, the EX plus medication group (intervention) and medication only group (control). EX on treadmill will be given three times weekly for 12 weeks at moderate intensity 50% to 85% of age-predicted maximum heart rate. Ovulatory function will be assessed at baseline, 4 weeks, 8weeks and 12 weeks and QOL at baseline and 12 weeks. This study might create awareness on the benefit of EX on anovulatory infertility among gynecologists.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied anovulatory infertility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 15/11/2017
Actual trial start date
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group aerobic exercise plus medication 3 times weekly 12 weeks Aerobic exercise will be conducted on treadmill 30 mimutes per session, there will be 5 minutes of warm up and 5 minutes of cool down 60
Control Group medication only will be determine by Gyneacologist 12 weeks medication for anovulatory infertility will be prescribed by the gyneacologist 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.All anovulatory infertility women who consent to participate in this research. 2.All anovulatory infertility women who are suitable for ovulation induction (WHO class I, II, and IV) (Mutsaerts et al, 2016) will be included in the study and this will be noted from the patients case files. 1.All anovulatory infertility women with medical condition that requires the use of prescribed medication such as cardiac, liver, renal disease and diabetes mellitus. 2.All anovulatory infertility women who are not suitable for ovulation induction (WHO class III) premature ovarian failure and those will genetic abnormalities. This will be noted from the patients case files. 3.All anovulatory infertility women who consume alcohol or smoke (Mutsaerts et al, 2016). 4.All anovulatory infertility women that tick a single ¿Yes¿ in Physical Activity Readiness Questionnaire (PAR-Q) (Appendix 1) will be excluded in the study. 5.All anovulatory infertility women who engage in any form of structured exercise 6 months before will be excluded. 15 Year(s) 44 Year(s) Female
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 25/09/2017 Health Research Ethics Committee, Ministry of Health, Kano
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, 2nd & 3rd Floor, Post office Road, Kano. Kano PMB 3066 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome progesteron level baseline, 4 weeks , 8 weeks, 12 weeks
Primary Outcome ovulation baseline, 4 weeks, 8weeks, 12 weeks
Primary Outcome regulaity of period baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Quality of life baseline and 12 weeks
Secondary Outcome BMI baseline, 12 weeks
Secondary Outcome body fat baseline, 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Muhammad Specialists Hospital No 145, MAW Road, K/ municipal LGA Kano PMB 3540 Nigeria
Aminu Kano teaching Hospital No. 2 new hospital road, Tarauni LGA Kano PMB 3452 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
H & M Nigeria Limited plot 58 Zaria road, trade fair complex area. Kano P.O. Box 11830 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor H & M Nigeria Limited plot 58 Zaria road, trade fair complex area. Kano P.O. Box 11830 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Department of physiotherapy, college of allied health sciences, Bayero university, kano Kano Kano PMB 3011 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rukayya Ibrahim Hassan ruqy23@yahoo.com +2348065848695 Kano
City Postal code Country Position/Affiliation
Kano PMB 3452 Nigeria Principal Physiotherapist, AKTH, KANO
Role Name Email Phone Street address
Public Enquiries Shmaila Hanif shelllshelll@yahoo.com +2348038871817 Department of Physiotherapy , Faculty of allied health sciences, college of health sciences, Bayero university, kano
City Postal code Country Position/Affiliation
kano P.M.B 3011 Nigeria Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Shmaila Hanif shelllshelll@yahoo.com +2348038871817 Kano
City Postal code Country Position/Affiliation
Kano P.M.B 3011 Nigeria Assistant Professor
REPORTING
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