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Clinical Trials/NCT05846386
NCT05846386CompletedNot Applicable

Effects of Early Resistance Training on Functional Capacity and Electrocardiographic Changes Post Valve Replacement Surgery

Cairo University2 sites in 1 country40 target enrollmentStarted: April 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
P-R interval (in milliseconds)

Study Overview

Brief Summary

Background: Recent recommendations from the European Society of Cardiology (ESC) are multidisciplinary cardiac rehabilitation including therapeutic exercises for patients after heart valve surgery unless there is insufficient evidence to decide whether therapeutic exercise cardiac training should be provided for such patients. As well, resistance training is an extremely safe systemic physical activity, and it has no contraindications if well-oriented, in addition to being the fastest-growing physical activity in the world in several practitioner settings.

Purpose: This study was conducted to investigate the effect of early resistance training on the fitness level (vo2 max) and (PR interval) of patients post-valve replacement surgery.

Detailed Description

Method: Forty males post-valve replacement surgery participants' age ranged from 20 to 30 years old and were selected randomly from National Heart Institute (Imbaba), this study was conducted in the period between April and November 2022, and those participants were allocated randomly into two equal groups twenty in each group. Group A received aerobic and resistance training three sessions per week for one-month, and group B received aerobic training three sessions per week for one month. All demographic data was recorded and an ECG device was used to record HR and R-P Intervals, Six-Minute Walk Test (6MWT) was used to assess of cardiorespiratory fitness for all participants in both groups (A&B)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants' age ranged from 20 to 30 years old,
  • Participants medically stable to do early resistance exercise in the first week after the operation.
  • Each participant had undergone valve replacement surgeries only,
  • Participants be able to do early resistance exercises in the first week after the operation.

Exclusion Criteria

  • The study excluded the participant if has one or more of the following criteria:
  • sternal infection and delay sternal healing.
  • Patient with a musculoskeletal condition limiting the ability to exercise or a geographical residence and/or lack of access to transportation, thus preventing exercise session attendance.
  • The patient has an LV thrombus diagnosed by echocardiography, left ventriculogram, or other imaging.
  • The patient is known to have unprotected left main coronary artery disease (CAD) greater than 50%.
  • Patients have poor cognitive capabilities or poor mentality.
  • Patient who had valve and CABG surgery.

Outcomes

Primary Outcomes

P-R interval (in milliseconds)

Time Frame: 4 weeks

represent a mortality index (the time from the beginning of atrial depolarization to the onset of ventricular depolarization) on the electrocardiograph

six minute walking distance (in meters)

Time Frame: 4 weeks

represent aerobic capacity (distance walked in 6 min)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hady Atef Labib

Lecturer of physiotherapy for cardiovascular/respiratory disorders

Cairo University

Study Sites (2)

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