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Recruiting NCT07205393

Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery

No phase Interventional Valve Replacement Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiac rehabilitation, Routine clinic care.
Who it may be relevant to
Registry conditions: Valve Replacement Surgery. Basic parameters: 40 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed 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.

Interventions

  • Other Cardiac rehabilitation
    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 e
  • Other Routine clinic care
    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).

Primary outcome measures

  • Oxygen saturation. [Time frame: 5 to 6 days]
  • FVC [Time frame: 5 to 6 days]
  • FEV1 [Time frame: 5 to 6 days]
  • FEV1/FVC. [Time frame: 5 to 6 days]
Secondary outcome measures (1)
  • The 6-Minute Walk Test (6MWT) [Time frame: 5 to 6 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • South valley university — Qina

Identifiers

NCT: NCT07205393 · P.T_INT_11/2024_553

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗