Effect of Phase I Cardiac Rehab With or Without Upper Limb Cycle Ergometer

NCT07128849 | Recruiting

• 1 other identifier: REC/RCR & AHS/24/0351
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the effects of an upper limb cycle ergometer in phase I CABG patients. This will likely enhance various outcomes such as quality of life, dyspnea, functional outcome measure, cardiovascular parameters, and upper limb mobility. If utilized, the arm ergometer may contribute to improve upper limb strength and endurance. This could result in improving upper limb range of motion and reducing the risk of adhesive capsulitis. This study will positively impact society by reducing morbidity and mortality rates, healthcare costs and ultimately improves patient care.

Conditions

CAD

Keywords

phase I cardiac rehabilitation; upper limb cycle ergometer; post op period CABG

Outcome Measures

Primary Outcomes (3)

• Functional independence Measure (FIM)

  There are eighteen items in the FIM, and each item has a maximum score of seven points, a minimum score of one point, and and a maximum score of 126 points overall. The FIM has eighteen items, of which thirteen are used to test motor ADL (six self-care items, two sphincter control tasks, three transfer items, and two motor items), and the other five are used to assess cognitive ADL (two items for communication and three items for social cognition).

  7 days

• 36- Item Short Form Survey Instrument

  The SF-36 brief survey, which includes 36 items across eight categories of QOL, is a standardised tool for assessing generic health concepts. It includes ten items related to physical functioning, four items related to physical problems, five items related to general mental health, three items related to emotional problems, and two items related to relationships with family and friends. General health, which includes six items regarding the patient's personal opinion of health; physical pain, which includes 2 items about the patient's body pain intensity; and energy or vitality, which includes four things about vitality, exhaustion, and tiredness. There are total 8 domains of SF-36 and its score range is from 0-100, the lower score means more disability and higher score means less disability

  7 days

• Modified Medical Research Council (MMRC) Dyspnea Scale

  During activity, the 5-item MMRC dyspnea scale was used to measure the severity of dyspnea. On this scale, the degree of dyspnea is rated from 0 (no dyspnea during ordinary activities or vigorous exercise) to 4 (dyspnea during routine activities). The patients were instructed to identify the number on the scale that most accurately represented their dyspnea after reading the descriptive comments. The reliability of the MMRC scale was computed with an intra-class correlation coefficient of 0.8, and the validity of the scale was thus established by using the perspectives of heart, lung, and nursing specialists through the use of the facial and qualitative content validity methodologies

  7 days

Secondary Outcomes (4)

• Heart Rate (HR)

  7 days

• Respiratory Rate (RR)

  7 Days

• Blood Pressure (BP)

  7 Days

• Oxygen Saturation

  7 Days

Study Arms (2)

upper limb exercise with arm ergometer

EXPERIMENTAL

Group A will receive upper limb exercise on arm ergometer lasting 5 min at 30 rpm (Rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day

Other: upper limb exercise with arm ergometer

upper limb exercise with out arm ergometer

ACTIVE COMPARATOR

Group B will receive standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day

Other: upper limb exercise with out arm ergometer

Interventions

upper limb exercise with arm ergometer OTHER

upper limb exercise on arm ergometer lasting 5 min at 30 rpm (Rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day

upper limb exercise with arm ergometer

upper limb exercise with out arm ergometer OTHER

standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day

upper limb exercise with out arm ergometer

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned CABG patients
• years
• Both male and female
• Hemodynamic stable patients
• Post extubation

You may not qualify if:

• Patients suffering from pulmonary diseases and thyroid disorders
• Mechanical ventilation more than 24 hr
• Mean arterial pressure i.e, \< 60 mmHg or \> 140 mmHg and heart rate not more than 120bpm
• Having an orthopedic condition that makes the use of upper and lower extremity impossible.
• Who have neurological impairment influencing breathing rate and heart rate.
• Who required the implantation of an intra-aortic balloon during surgery
• Who experienced postoperative complications such as pulmonary embolism

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gulab Devi Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (6)

• Organization WH. Cardiovascular diseases (CVDs). 2021.

  BACKGROUND

• Bachar BJ, Manna B. Coronary Artery Bypass Graft. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507836/

  PMID: 29939613 BACKGROUND

• Alexander JH, Smith PK. Coronary-Artery Bypass Grafting. N Engl J Med. 2016 Sep 8;375(10):e22. doi: 10.1056/NEJMc1608042. No abstract available.

  PMID: 27602683 BACKGROUND

• Dimopoulos S, Raidou V, Elaiopoulos D, Chatzivasiloglou F, Markantonaki D, Lyberopoulou E, Vasileiadis I, Marathias K, Nanas S, Karabinis A. Sonographic muscle mass assessment in patients after cardiac surgery. World J Cardiol. 2020 Jul 26;12(7):351-361. doi: 10.4330/wjc.v12.i7.351.

  PMID: 32843937 BACKGROUND

• Cordeiro ALL, Mascarenhas HC, Landerson L, Araujo JDS, Borges DL, Melo TA, Guimaraes A, Petto J. Inspiratory Muscle Training Based on Anaerobic Threshold on the Functional Capacity of Patients After Coronary Artery Bypass Grafting: Clinical Trial. Braz J Cardiovasc Surg. 2020 Dec 1;35(6):942-949. doi: 10.21470/1678-9741-2019-0448.

  PMID: 33113311 BACKGROUND

• Hossein Pour AH, Gholami M, Saki M, Birjandi M. The effect of inspiratory muscle training on fatigue and dyspnea in patients with heart failure: A randomized, controlled trial. Jpn J Nurs Sci. 2020 Apr;17(2):e12290. doi: 10.1111/jjns.12290. Epub 2019 Aug 19.

  PMID: 31429207 BACKGROUND

Study Officials

• Iram Nawaz, Mphill

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 19, 2025
• Study Start: July 17, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)