Health TrialsbyHealthPanel

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

ConditionCAD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Planned CABG patients

40-65 years

Both male and female

Hemodynamic stable patients

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • upper limb exercise with arm ergometer

    Other intervention

    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 out arm ergometer

    Other intervention

    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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: upper limb exercise with arm ergometerExperimental treatment 1 intervention
Group B: upper limb exercise with out arm ergometerActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
7 days
2

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

Time frame
7 days
3

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

Time frame
7 days

Secondary outcomes

1

Heart Rate (HR)

Cardiac monitors in ICU/CCU settings will be used to measure heart rate (HR).

Time frame
7 days
2

Respiratory Rate (RR)

Cardiac monitors in ICU/ CCU will be used to measure respiratory rate (RR).

Time frame
7 Days
3

Blood Pressure (BP)

Cardiac monitors in ICU / CCU will be used to measure blood pressure (B.P).

Time frame
7 Days
4

Oxygen Saturation

Cardiac monitors in ICU / CCU will be used to measure Oxygen saturation.

Time frame
7 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riphah International University

Lead sponsor

Source ClinicalTrials.gov
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