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.: PACTR202208780980761 Date of Approval: 05/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effects of Slow-Paced Breathing Intervention on Heart Rate Variability, Postural Balance, Cognition, Functional Performance, and Quality of Life in Middle-Aged Women
Official scientific title The Effects of Slow-Paced Breathing Intervention on Heart Rate Variability, Postural Balance, Cognition, Functional Performance, and Quality of Life in Middle-Aged Women
Brief summary describing the background and objectives of the trial Aging brings a series of biological, psychological, and functional changes such as heart rate variability, balance, cognition, and aerobic capacity. Slow-paced breathing has been found to improve those impairments in different populations. The aim of this study is to assess the effect of slow-paced breathing on heart rate variability, balance, cognition, functional performance, and quality of life in middle-aged post-menopausal women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postural instability
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/07/2022
Actual trial start date 01/07/2022
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date 31/08/2024
Anticipated target sample size (number of participants) 25
Actual target sample size (number of participants) 30
Recruitment status Completed
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 15 minutes of slow paced breathing 15 minutes daily 12 weeks One week prior to measurements participants will undergo a familiarization session. The next day participants will be welcomed into the laboratory for measurements. First, we will assess the heart rate and root mean square of successive differences via Welltory application, and the postural balance using a static stabilometric platform (posture Win©, Techno Concept ®, Cereste, France; 40 Hz frequency, 12-bits A/D conversion). After finishing the measurements, participants will be provided with a video that shows a circle that goes full during 4 seconds and then vanishes during 6 seconds. They will be asked to follow the circle while inhaling through the nose and exhaling through pursed lips respectively. They will practice the slow paced breathing for 12 weeks and will undergo measurements' sessions every 4 weeks. 15
Control Group no intervention nothing 12 weeks We will assess the heart rate and root mean square of successive differences via Welltory application, and the postural balance using a static stabilometric platform (posture Win©, Techno Concept ®, Cereste, France; 40 Hz frequency, 12-bits A/D conversion). After finishing the measurements, participants will be asked not to change anything about their daily activities for 12 weeks. We will keep track of them through phone calls. They will undergo measurements' sessions every 4 weeks. 15 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Females 45–65 years old at least 12 months of amenorrhea willing to provide their written informed consent to participate Being under hormonal replacement therapy taking vestibular sedatives or other central nervous system depressants suffering from any chronic or severe medical diseases or any neuropsychiatric disorder that could limit balance and/or that could influence breathing or heart rate patterns. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 65 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 postural balance pre-intervention, immediately post-intervention and every 4 weeks for 12 weeks
Secondary Outcome heart rate and root mean square of successive differences, cognitive function, functional performance and quality of life pre-intervention, immediately post-intervention and every 4 weeks for 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Laboratory EM2S Road El Matar km 3.5 Sfax Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Karama Masmoudi road Saltania Km 6 sfax Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratory EM2S road el Matar 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 km 6
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