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

01 Apr 2022

The date of last modification

Apr 01, 2022



Application Summary


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


Trial Details


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

  1. Patients who have lesser than two weeks of waiting time for the date of surgery,
  2. Patients who have a history of stroke,
  3. Patients who have used immunosuppressive medication for 30 days before surgery.
  4. Patients with neuromuscular disorders.
  5. Patients suffering with low back pain and abdominal muscle strains
  6. Patients who have an aneurysm or aortic dissection.
  7. Patients who have severe heart failure (New York Heart Association Class IV) or unstable angina (Canadian Cardiovascular Society Class IV) symptoms.
  8. Patients who have uncontrolled hypertension (systolic blood pressure >= 160 mm Hg and/or diastolic blood pressure >=100 mm Hg)
  9. Patients who have uncontrolled atrial or ventricular arrhythmias or uncontrolled sinus tachycardia (>120 beats min?1)
  10. Patients who have low ejection fraction pre-op (<40%).
  11. Patients who have a recent history of congestive heart failure that has not been evaluated and effectively treated.
  12. Patients who have severe aortic or mitral stenotic or regurgitate valvular disease ( severe aortic or mitral stenosis - aortic or mitral valve area < 1.0 cm2 or mean gradient > 40 or >10 mmHg respectively),
  13. Patients with severe asthma (asthma that remains ‘uncontrolled’ despite optimized treatment with high dose– Inhaled corticosteroids (ICS) - Long acting beta2 agonist (LABA), or that requires high dose ICS- LABA to prevent it becoming ‘uncontrolled') and on bronchodilators.
  14. Patients who have hypertrophic cardiomyopathy.
  15. Patients undergoing combined procedures.
  16. Patients who have a recent history of congestive heart failure that has not been evaluated and effectively treated.
  17. Patients who have active pericarditis or myocarditis.
  18. Patients who had recent embolism (pulmonary or systemic).
  19. Patients who have acute thrombophlebitis.
  20. Patients who have cognitive deficits that would preclude participation to the exercise program.
  21. Patients who have physical limitations that would preclude participation to the exercise program.
  22. Patients who are unable to attend the exercise program.


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.

]
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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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization







Secondary study sponsor (If any)







Trial Completion details


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