Early Resistance Training Post Valve Replacement Surgery

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05846386
Collaborator
RMIT University, Melbourne, Australia (Other), Federation University Australia (Other)
40
1
2
8
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Resistance training
  • Behavioral: Aerobic training
N/A

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
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Early Resistance Training on Functional Capacity and Electrocardiographic Changes Post Valve Replacement Surgery
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Nov 30, 2022
Actual Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aerobic and resistance training

aerobic exercises (intervention) on arm ergometer and resistance training using weights for post valve replacement surgery patients for 4 weeks, 3 times/week for the duration of 45-70 min/ session.

Behavioral: Resistance training
moderate-intensity resistance training: three sessions per week for one month. Participants had been instructed to perform exercises at a 4:2:4 tempo; that is, four sets of concentric contraction, two sets of isometric hold, and four sets of eccentric contraction. Participants had been instructed to complete a single set until volitional fatigue or been instructed to stop by the physiotherapist when the technique falters

Behavioral: Aerobic training
The exercise program consisted of ten minutes warm-up, 45 minutes of moderate aerobic exercises "upper extremity aerobic bulk muscles training and arm ergometer" and cool-down in five minutes, respectively. That was done as 3 sessions/week for 4 weeks.

Active Comparator: Aerobic training

aerobic exercises (intervention) on arm ergometer for post valve replacement surgery patients for 4 weeks, 3 times/week for the duration of 30-55 min/ session.

Behavioral: Aerobic training
The exercise program consisted of ten minutes warm-up, 45 minutes of moderate aerobic exercises "upper extremity aerobic bulk muscles training and arm ergometer" and cool-down in five minutes, respectively. That was done as 3 sessions/week for 4 weeks.

Outcome Measures

Primary Outcome Measures

  1. six minute walking distance (in meters) [4 weeks]

    represent aerobic capacity (distance walked in 6 min)

  2. P-R interval (in milliseconds) [4 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National heart institute Giza Cairo Egypt 11262

Sponsors and Collaborators

  • Cairo University
  • RMIT University, Melbourne, Australia
  • Federation University Australia

Investigators

  • Principal Investigator: Hady Atef, Ph.D., Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hady Atef Labib, Lecturer of physiotherapy for cardiovascular/respiratory disorders, Cairo University
ClinicalTrials.gov Identifier:
NCT05846386
Other Study ID Numbers:
  • post valve replacement
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hady Atef Labib, Lecturer of physiotherapy for cardiovascular/respiratory disorders, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023