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IRCT20180417039344N2 IRCT 2019-10-11 Kulsum International Hospital Effects of pre-operative physiotherapy on subjects going for CABG Effects of pre-operative physiotherapy on functional capacity, kinesiophobia and post operative ICU stay in subjects with Coronary artery disease (CAD) going for Coronary atrery bypass grafting (CABG) 2019-03-16 anticipated 50 Complete https://irct.ir/trial/38915 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Subjects will be randomly divided into two groups by using concealed envelope method, in which there will be two envelopes. One envelope will contain a piece of paper with control group written on it, while the other will have experimental group written on the piece of paper enclosed in. First participant will choose one envelope and will hand it over to the investigator, the investigator will open the envelope and will allocate the participant into the group mentioned in the envelope (e.g. experimental group) without letting the participant know about which group he/ she will belong to. The next participant will be considered to be in the other group (control group). Then the third will come and choose the envelope, and the same process will be followed again till last participant, Blinding description: There will be blinding of the care provider , they would not be informed about the participants of both groups. The outcome assessor will also be blinded regarding the type of intervention group the subject belongs to. N/A Coronary Artery Disease. Intervention 1: Intervention group: Subjects will be provided inspiratory muscle training, breathing exercises and also chest clearance techniques. Three sessions will be given of 30-40 minutes each prior to their surgery. Inspiratory muscle training will be direct gentle resistance in inward and upward direction below xiphoid process during inspiration. To enhance thoracic expansion, incentive spirometer will also be used. Chest clearance will be done by active cycle of breathing technique (ACBT) and manual therapeutic chest percussion. Intervention 2: Control Group: Subjects will be provided breathing exercises and also chest clearance techniques, 3 sessions of 30-40 minutes each. Yes - There is a plan to make this available What will be shared: Personal details would not be shared, although data related to study, outcomes and procedures will be shared. When: August 2019 To whom: All the professionals working in clinical settings or in academia, undergraduate and post graduate students in the relevant field Conditions: Data would be shared for use for betterment of patients, and requests will be reviewed by investigators of the study Where to obtain: Via email to kiran_dpt.ahs@stmu.edu.pk How to obtain: kiran_dpt.ahs@stmu.edu.pk An email with data sharing request to the mentioned mailing address will lead to sharing of data regarding the study Comments:
public Kiran Khushnood
Dar-ul-Shifa Campus, Street 3, H8/1
Islamabad Pakistan 44000 +92 51 8441750 kiran_dpt.ahs@stmu.edu.pk Shifa Tameer-e-Millat University scientific Kiran Khushnood
Dar-ul-Shifa Campus, Street 3, H8/1
Islamabad Pakistan 44000 +92 51 8441750 kiran_dpt.ahs@stmu.edu.pk Shifa Tameer-e-Millat University Pakistan Ejection Fraction of ≥ 25% Exercise intensity of below anginal threshold Able to perform 6 minute walk test Able to tolerate mild to moderate activities 25 years 60 years Both Individuals with other systemic diseases Previous surgical procedures Subjects with any neurological or cognitive impairment I25 Chronic ischemic heart disease Rehabilitation Rehabilitation Intervention group: Subjects will be provided inspiratory muscle training, breathing exercises and also chest clearance techniques. Three sessions will be given of 30-40 minutes each prior to their surgery. Inspiratory muscle training will be direct gentle resistance in inward and upward direction below xiphoid process during inspiration. To enhance thoracic expansion, incentive spirometer will also be used. Chest clearance will be done by active cycle of breathing technique (ACBT) and manual therapeutic chest percussion. Control Group: Subjects will be provided breathing exercises and also chest clearance techniques, 3 sessions of 30-40 minutes each Functional capacity. Timepoint: At baseline before physiotherapy session, then after 3 physiotherapy sessions, and again after surgical procedure. Method of measurement: By 6 minute walk test. Kinesiophobia. Timepoint: At baseline before physiotherapy session, then after 3 physiotherapy sessions, and again after surgical procedure. Method of measurement: Tampa scale of Kinesiophobia for heart. Cardiovascular and pulmonary endurance. Timepoint: At baseline before physiotherapy session, then after 3 physiotherapy sessions, and again after surgical procedure. Method of measurement: VO2 max and BORG scale. Stay in ICU. Timepoint: After surgical procedure in ICU. Method of measurement: By measuring number of days a subject stays in ICU after surgical procedure. Kulsum International Hospital Approved 2019-03-08 Ethical Committee, Kulsum International Hospital 2020 Kulsum Plaza Islamabad Islamabad Capital Territory Pakistan