Home » Trials » SLCTR/2022/007
Physiotherapy led Preoperative Abdominal Muscle Training to Prevent Postoperative Respiratory Complications following Cardiac Surgery
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SLCTR Registration Number
SLCTR/2022/007
Date of Registration
The date of last modification
Jan 11, 2023
Scientific Title of Trial
Physiotherapy led Preoperative Abdominal Muscle Training to Prevent Postoperative Respiratory Complications following Cardiac Surgery
Public Title of Trial
Abdominal muscle training prior to surgery, to reduce the occurrence of postoperative pulmonary complications in postoperative cardiac surgery patients compared to standard care : a randomized control trial.
Disease or Health Condition(s) Studied
Post cardiac surgery pulmonary complications
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1273-5246
Any other number(s) assigned to the trial and issuing authority
P/83/08/2021
What is the research question being addressed?
Is abdominal muscle training prior to surgery effective in reducing the occurrence of postoperative pulmonary complications in postoperative cardiac surgery patients compared to usual care?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study setting - This study will be conducted at the National Hospital of Sri Lanka.
Method of randomization- A computer-generated randomization table will be used for simple randomization. Randomization will be done by an independent investigator who will not be involved in the recruitment, treatment or assessment of patients
Intervention- The intervention is a pre-operative abdominal muscle training program. Three exercises will be used for the pre-operative abdominal muscle training program. The training will commence two weeks prior to the scheduled date of surgery and conducted for two weeks prior to the surgery.
The training will be conducted under supervision of a physiotherapist. Exercises of the program will be resistance exercises with body weight and/or free weights and conducted for three days per week with at least 48 hours separating the exercise training sessions. The FITT-VP (Frequency, Intensity, Time, Type, Volume, and Progression) principle will be used to describe the exercises for abdominal muscle training for patients with cardiac conditions. The description of the exercise program based on the FITT-VP principle is as follows. Frequency - The resistance exercises of the training can be performed on three non-consecutive days per week. Intensity - the resistance exercises can initially be performed 10-15 repetitions with initial RPE 11-13 on 6-20 Borg scale; performing 10-15 repetitions or 40%-60% of one-repetition maximum (1RM). RPE (Rating of Perceived Exertion) is a way of measuring physical activity intensity level. Borg RPE scale is used for rating exertion and breathlessness during physical activity; that is, how hard the activity is as shown by high heart and respiration rate, profuse perspiration and muscle exertion.
1-RM is the greatest resistance/weight that can be moved through the full range of motion for a single repetition in a controlled manner with good posture. Time - Each resistant exercise of the training can be conducted for 1-3 sets with a rest interval of 2–3 min between each set. Type - resistance exercises can be conducted with body weight and/or free weights. Exercised will be commenced with body weight, and free weights will be introduced according to the progression of individual patients. Volume - exercise volume is the product of Frequency, Intensity, and Time (duration) of exercise. In this resistance training program, the volume should be considered in the progression of the training. Progression - resistance exercises can be progressed by increasing training volume in 2%–10% increments when an individual patient can comfortably complete one to two sets over the desired number of repetitions on two consecutive training days.
Usual Care - patients waiting for cardiac surgery receive incentive spirometer exercises, deep breathing exercises and advice on sternal precautions and postoperative physiotherapy, 1-2 weeks prior to the scheduled surgery date. They will be instructed to perform incentive spirometer exercises, deep breathing exercises 3 times a day.
The outcome assessment will be done by independent investigator who will not involve in the recruitment, randomization or treatment of patients.
Inclusion criteria
Adult male and female patients (age >=18), scheduled for any type of elective cardiac surgery.
Exclusion criteria
Primary outcome(s)
1.
The occurrence of postoperative pulmonary complications, from the time of admission to the intensive care unit to the discharge from the hospital.The occurrence of postoperative pulmonary complications will be scored on an ordinal scale of 1 to 4, using the operational definition of Kroenke et al. |
[ From the time of admission to the intensive care unit to the discharge from the hospital. ] |
Secondary outcome(s)
1.
“Time duration to extubation”, from the commencement of invasive mechanical ventilation to the removal of invasive mechanical ventilation (extubation) in the intensive care unit. The time points of the commencement of invasive mechanical ventilation and the removal of invasive mechanical ventilation will be recorded and used to calculate the duration of the "time duration to extubation". The time duration will be calculated in the number of minutes. |
[ From the commencement of invasive mechanical ventilation to the removal of invasive mechanical ventilation (extubation) ] |
2.
“Time duration to discontinue non-invasive oxygen therapy”, from the commencement of non-invasive oxygen therapy to the discontinuation of non-invasive oxygen therapy in the intensive care unit.The time points of the commencement of non-invasive oxygen therapy and the discontinuation of non-invasive oxygen therapy will be recorded and used to calculate the “time duration to discontinue non-invasive oxygen therapy”. The time duration will be calculated in the number of hours and provided to two decimal points. |
[ From the commencement of non-invasive oxygen therapy to the discontinuation of non-invasive oxygen therapy in the intensive care unit. ] |
3.
“Length of stay in the intensive care unit” from the admission to the intensive care unit to the discharge from the intensive care unit. The time point of admission to the intensive care unit after the surgery and discharge from the intensive care unit will be recorded and used to calculate length of stay in the intensive care unit. The length of stay in the intensive care unit will be calculated in number of hours and provided to two decimal points. |
[ From the time point of admission to the intensive care unit after the surgery to discharge from the intensive care unit. ] |
4.
“Length of stay in the hospital” from date of admission to intensive care unit to the date of discharge from the hospital. The dates of admission to the intensive care unit after the surgery and discharge from the hospital will be recorded and used to calculate the length of stay in the hospital. The time duration will be calculated in number of days considering the date of admission to the intensive care unit and discharge from the hospital, irrespective to the time of admission and discharge. |
[ From the date of admission to the intensive care unit after the surgery to discharge from the hospital. ] |
5.
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Target number/sample size
652 patients (326 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2022-04-02
Anticipated end date
2023-01-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self Funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2021-12-14
Approval number
P/83/08/2021
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka |
Telephone: | +94 -112961267/ +94 -112961000, |
Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
T.M.U. Sanjeewa Thunpaththu
Physiotherapist
National Hospital of Sri Lanka, Colombo
0706441707
stunpattu@gmail.com
Contact Person for Public Queries
Madawa Chandratilake
Cadre Chair & Professor of Medical Education Head, Department of Medical Education Faculty of Medicine University of Kelaniya.
Department of Medical Education
Faculty of Medicine
University of Kelaniya
0770122795
mnchandratilake@kln.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results