Clinical trial NCT05846386: Early Resistance Training Post Valve Replacement Surgery
Official title: Effects of Early Resistance Training on Functional Capacity and Electrocardiographic Changes Post Valve Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valve Disease, Heart
Keywords: post valve replacement
resistance exercise
aerobic exercise
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: RMIT University, Melbourne, Australia
name: Federation University Australia
First posted: 2023-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: Inclusion Criteria:

1. Participants' age ranged from 20 to 30 years old,
2. Participants medically stable to do early resistance exercise in the first week after the operation.
3. Each participant had undergone valve replacement surgeries only,
4. 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.

Primary outcomes:
measure: six minute walking distance (in meters)
timeFrame: 4 weeks
measure: P-R interval (in milliseconds)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National heart institute
state: Cairo
Study officials:
affiliation: Cairo University
name: Hady Atef, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: