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Coronary Artery Bypass GraftNCT04993976

Prehabilitation and Coronary Artery Bypass Grafting

A study testing Resistant training (Prehabilitation) in people with Coronary Artery Bypass Graft, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Coronary Artery Bypass Graft
What is being tested?
Resistant training (Prehabilitation)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 sitePakistan
Study dates
1 Mar 2021to 1 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Faisalabad Institute of Cardiology.

    Faisalābad, Punjab Province, 38000

Other trials in Pakistan

About this study

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

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.

Read the detailed description

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

Being tested
Resistant training (Prehabilitation), Active Comparator: Control group
Keywords
CABG, Fraility, Prehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 groupOther

    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.

Study groups in NCT04993976
Study groupRoleWhat they receive
Prehabilitation groupExperimentalStrength training along with warm-up and cool down for 8 weeks
Receives: Other: Resistant training (Prehabilitation)
Control groupActive comparatorSupervised Standard care plan for 8 weeks
Receives: Other: Active Comparator: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frailty

    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.

    Measured: 8 weeks

Secondary outcomes (1)

  1. Functional capacity

    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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start1 Mar 2021
  3. Primary completion1 Aug 2021
  4. Study completion1 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04993976
Sponsor's protocol ID
Rec/00980 Wajeeha Sahar
Status last verified
Dec 2021
First submitted
5 Aug 2021
Last updated
15 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Afilalo J, Lauck S, Kim DH, Lefevre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Genereux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7.

    PubMed 28693934

  • Sepehri A, Beggs T, Hassan A, Rigatto C, Shaw-Daigle C, Tangri N, Arora RC. The impact of frailty on outcomes after cardiac surgery: a systematic review. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3110-7. doi: 10.1016/j.jtcvs.2014.07.087. Epub 2014 Aug 7.

    PubMed 25199821

  • Stammers AN, Kehler DS, Afilalo J, Avery LJ, Bagshaw SM, Grocott HP, Legare JF, Logsetty S, Metge C, Nguyen T, Rockwood K, Sareen J, Sawatzky JA, Tangri N, Giacomantonio N, Hassan A, Duhamel TA, Arora RC. Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial. BMJ Open. 2015 Mar 9;5(3):e007250. doi: 10.1136/bmjopen-2014-007250.

    PubMed 25753362

  • Afilalo J, Kim S, O'Brien S, Brennan JM, Edwards FH, Mack MJ, McClurken JB, Cleveland JC Jr, Smith PK, Shahian DM, Alexander KP. Gait Speed and Operative Mortality in Older Adults Following Cardiac Surgery. JAMA Cardiol. 2016 Jun 1;1(3):314-21. doi: 10.1001/jamacardio.2016.0316.

    PubMed 27438112

  • Sahar W, Waseem M, Riaz M, Nazeer N, Ahmad M, Haider Z. Effects of prehabilitation resistance training in mild to moderate clinically frail patients awaiting coronary artery bypass graft surgery. J Investig Med. 2024 Jan;72(1):151-158. doi: 10.1177/10815589231207795. Epub 2023 Oct 30.

    PubMed 37804162

Questions about this trial

What is this clinical trial studying?

A study testing Resistant training (Prehabilitation) in people with Coronary Artery Bypass Graft, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04993976, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.

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