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Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery

S

South Valley University

Status

Enrolling

Conditions

Valve Replacement Surgery

Treatments

Other: Cardiac rehabilitation
Other: Routine clinic care

Study type

Interventional

Funder types

Other

Identifiers

NCT07205393
P.T_INT_11/2024_553

Details and patient eligibility

About

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.

Full description

A 60 patients aged 40 to 60 years who had received mitral or aortic valve replacement were allocated randomly into two groups equal in numbers, the first one (cardiac rehabilitation group) participated in a phase one cardiac rehabilitation program comprising supervised physical exercises and respiratory training, the second one (control group) underwent routine physical therapy program. The outcomes were oxygen saturation measurements, spirometry measures and Six minutes walk test. All measured variables were evaluated before and after six consecutive weeks of rehabilitation for all patients.

Enrollment

60 estimated patients

Sex

All

Ages

40 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • uncontrolled arrhythmias.
  • Comorbidity complicating physical activity or other contraindications to phase one cardiac rehabilitation and Patients who underwent an emergency surgical intervention.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Cardiac rehabilitation
Other group
Description:
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 sessions 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.
Treatment:
Other: Routine clinic care
Other: Cardiac rehabilitation
Control group
Other group
Description:
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). Data collection The investigators assessed all patients on the day before surgery (baseline assessment) and the day of hospital discharge.
Treatment:
Other: Routine clinic care

Trial contacts and locations

1

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Central trial contact

Shymaa Yussuf Abo-Zaid, Lecturer

Data sourced from clinicaltrials.gov

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