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Completed

NCT Number: NCT04993976

Prehabilitation and Coronary Artery Bypass Grafting

To evaluate the effects of Prehabilitation Resistance training on frailty and functional capacity in mild to moderate clinically frail patients awaiting Coronary Artery Bypass Grafting) CABG. This study will contribute to describing the effect of resistance training in mild to moderate frails patients and were directed to be the part of cardiac rehabilitation and define the effects of cardiac prehabilitation and to check whether the effects of resistance training or routine training is similar for quality of recovery in mild to moderate frails patients which undergone CABG.

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Key information

Conditions

Coronary Artery Bypass Graft

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faisalabad Institute of Cardiology.

Faisalābad, Punjab Province, 38000, Pakistan

About this study

In literature, Coronary Artery Bypass Graft (CABG) is a form of heart surgery that redirects blood around clogged arteries to increase blood flow and oxygen to the heart. During CABG surgery, the surgeon uses a portion of a healthy vessel (either an artery or vein) from the leg, chest, or arm to create a bypass around the clogged artery. During CABG surgery with cardiopulmonary bypass, a heart-lung machine artificially maintains circulation blood and oxygenation while the surgeon operates on the heart. It includes exercise, lifestyle changes, education, and emotional support. It can help improve patient's health and enable them to live a more active life after the patient has had a heart attack or heart surgery or if the patient has long-term heart problems such as heart failure.

The time spent waiting for cardiac surgery to be scheduled is a period of great uncertainty for a patient. There appears to be heightened anxiety regarding the inclusion of physical activity in this time period, mainly as a result of their current cardiac condition or diagnosis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing elective primary isolated coronary artery bypass grafting,
  • Patients with double and triple-vessel coronary artery disease.
  • Mild to moderately frail patients with a clinical frailty score of 5 -6 at the time of accepting surgery at the outpatient cardiothoracic surgical clinic.

Exclusion criteria

  • Patient with musculoskeletal disability and neurological disability affecting respiratory rate.
  • Patient with renal dysfunction requiring dialysis, use of immunosuppressive treatments during the 30-day period before surgery,
  • Left ventricular ejection fraction <30%
  • concomitant valve disease
  • Patient having dysrhythmias or pacemaker dependent
  • Those patients who are severely frail (CFS 7-9)

Treatment and study plan

Resistant training (Prehabilitation)

Other

Resistance training (10-15 repetitions: major muscle groups of upper and lower limbs [eg, shoulder overhead press, biceps curl, knee lift, and quadriceps extension in sitting and hamstrings curl exercises], one to three sets each) for 20-60 minutes five days a week.

Active Comparator: Control group

Other

Conventional physiotherapy group followed basic pre-operative respiratory physiotherapy including deep breathing exercises, instructions in coughing techniques, mobilization, and active exercises of the upper limbs and thorax. Walk 30 m in the hospital ward.

Primary outcomes

  1. Frailty

    Time frame: 8 weeks

    It is a scale ranges from 1 (very fit) to 9 (terminally ill). with common cut-off categories classified as non-frail (scores 1-3), vulnerable/ pre-frail (score 4) and frailty (scores 5-9). it is a simple, quick and highly predictive semi-quantitative tool.

Secondary outcomes

  1. Functional capacity

    Time frame: 8 weeks

    It is measured through six minute walk test which is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Resistance Training in Mild to Moderate Clinically Frail Patients Awaiting Coronary Artery Bypass Graft.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2021
Registry last updated
Dec 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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