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Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery

ConditionValve Replacement Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-55
SponsorSouth Valley University

About this trial

Cardiac rehabilitation is a crucial component of postoperative recovery for patients who have received valve replacement surgery. Aim: This study aimed to evaluate the effectiveness of phase one cardiac rehabilitation in improving cardiovascular function, pulmonary capacity, functional ability, and quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The inclusion criteria was elective mitral or aortic valve replacement

and to be hemodynamically stable to qualify for a structured rehabilitation program.

Being able to understand and complete measurements.

And provide informed written consent.

Disqualifiers

Patient with ischemic heart disease before surgery.

Those with severe musculoskeletal system disorders.

Patients who had persistent or paroxysmal atrial fibrillation.

Individuals with severe heart failure.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cardiac rehabilitation

    Other intervention

    The intervention group underwent the cardiac rehabilitation program from the first day following surgery regarding the clinical guideline for rehabilitation in patients with cardiovascular disease.17 This rehabilitation exercise program formed of breathing exercises, lower and upper extremity exercises in bed, sitting on the edge of the bed, standing at the bedside, and walking around the bed and for 100 m in the ward. The patient performed three sessions per day, with approximately 20 minutes each time. After the rehabilitation exercise, patients continued with gait practice for up to 500 m and carried out endurance training by using a stationary bike in the rehabilitation center of the hospital. The essions continued until they were discharged from the hospital (approximately 5 to 6 days post operative). The intensity of physical activity was limited by clinical conditions and activity tolerance, and monitored and assessed by physical therapists. Plus routine clinical care

  • Routine clinic care

    Other intervention

    The control group did not joined any rehabilitation program and only received routine clinical care during the duration of the hospital stay (approximately 5 to 6 days post operative).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cardiac rehabilitationOther 2 interventions
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Oxygen saturation.

Oxygen saturation: (2700 Branshaj, Denemark).

Time frame
5 to 6 days
2

FVC

Forced vital capacity (FVC)

Time frame
5 to 6 days
3

FEV1

forced expiratory volume in the first second (FEV1)

Time frame
5 to 6 days
4

FEV1/FVC.

The ratio of FEV1 on FVC.

Time frame
5 to 6 days

Secondary outcomes

1

The 6-Minute Walk Test (6MWT)

The 6-Minute Walk Test (6MWT): We performed the 6-minute walking test (6MWT), which involved measurement of the 6-minute walking distance and is a submaximal functional test indicative of performing daily activities.18 The safety and feasibility of this test have led to its use in cardiovascular rehabilitation.

Time frame
5 to 6 days

Other outcomes

Sponsors and contacts

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

South Valley University

Lead sponsor

Source ClinicalTrials.gov
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