NCT04993976

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

August 5, 2021

Last Update Submit

December 13, 2021

Conditions

Keywords

CABGFrailityPrehabilitation

Outcome Measures

Primary Outcomes (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.

    8 weeks

Secondary Outcomes (1)

  • Functional capacity

    8 weeks

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

Strength training along with warm-up and cool down for 8 weeks

Other: Resistant training (Prehabilitation)

Control group

ACTIVE COMPARATOR

Supervised Standard care plan for 8 weeks

Other: Active Comparator: Control group

Interventions

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.

Prehabilitation group

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.

Control group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faisalabad Institute of Cardiology.

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 28693934BACKGROUND
  • 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.

    PMID: 25199821BACKGROUND
  • 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.

    PMID: 25753362BACKGROUND
  • 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.

    PMID: 27438112BACKGROUND
  • 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.

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mehwish Waseem, MSPT(CPPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2021

First Posted

August 6, 2021

Study Start

March 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

December 15, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations