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.: PACTR202405872609260 Date of Registration: 15/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title effects of 12 weeks of concurrent training in middle-aged women
Official scientific title Déficiences fonctionnels, cognitifs et psychologiques, et de la stabilité posturale chez les femmes ménopausées: différentes modalités de traitement
Brief summary describing the background and objectives of the trial Concurrent training combines aerobic and resistance exercises. The beneficial effects of concurrent training on cardiorespiratory health, functional capacity, and cognitive performance have been reported. The aim of this study is to assess the effect of 12 weeks of concurrent training on heart rate variability, postural balance, cognition, functional performance and psychological aspects in middle-aged women
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied aging
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/12/2023
Actual trial start date 01/12/2023
Anticipated date of last follow up 10/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group slow paced breathing 12 weeks participants will practice 15 minutes of slow-paced breathing 3 times per week 8
Experimental Group concurrent training 12 weeks participants will practice concurrent training which is a combination of aerobic and resistance training 3 times per week 8
Control Group control group 12 weeks participants will continue their daily life activities 8 Placebo
Experimental Group combined group 12 weeks this group will practice concurrent training and slow-paced breathing combined 8
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age between 50-60 postmenopausal for 5 years low activity levels on IPAQ being free of cardiovascular and neuromuscular disorders have a score >26 on MMSE artificial prosthesis participation in any periodised training programme in the past 3 months having any disease that contraindicated the exercise program or required special care (i.e., coronary artery disease, thrombosis, moderate or severe bone, lung or renal diseases) having any disease requiring the daily intake of drugs affecting the athletic performance being smoker under hormonal replacement therapy actively practicing breathing exercises in the past 1 month taking vestibular sedatives or other central nervous system depressants, and/or suffering from any chronic or severe medical diseases or any neuropsychiatric disorder that could limit postural balance and/or that could influence breathing or heart rate patterns Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 60 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 17/05/2022 Committee of Protection of Persons in south
Ethics Committee Address
Street address City Postal code Country
Road Manzel Cheker sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome heart rate variability pre-intervention, during intervention at 6 and 12 weeks
Secondary Outcome heart rate pre-intervention, during intervention at 6 and 12 weeks
Primary Outcome Postural balance pre-intervention, during intervention at 6 and 12 weeks
Primary Outcome cognitive functions pre-intervention, during intervention at 6 and 12 weeks
Primary Outcome functional performance pre-intervention, during intervention at 6 and 12 weeks
Primary Outcome anxiety and depression pre-intervention, during intervention at 6 and 12 weeks
Primary Outcome sleep quality pre-intervention, during intervention at 6 and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Higher Institute of Sport and Physical Education of Sfax airoport road sfax Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Karama road salatania sfax Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor research lab EM2S road airoport km 3.5 sfax Tunisia Laboratory
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator karama masmoudi masmoudi.karama@yahoo.fr +21653652391 road saltania
City Postal code Country Position/Affiliation
sfax Tunisia LR19JS01
Role Name Email Phone Street address
Public Enquiries karama masmoudi masmoudi.karama@yahoo.fr +21653652391 road saltania
City Postal code Country Position/Affiliation
sfax Tunisia LR19JS01
Role Name Email Phone Street address
Scientific Enquiries karama masmoudi masmoudi.karama@yahoo.fr +21653652391 road saltania
City Postal code Country Position/Affiliation
sfax Tunisia LR19JS01
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form 12 months following article's publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information