Back to resultsEarly Resistance Training Post Valve Replacement Surgery
Primary Purpose
Valve Disease, Heart
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Resistance training
Aerobic training
Sponsored by
About this trial
This is an interventional treatment trial for Valve Disease, Heart focused on measuring post valve replacement, resistance exercise, aerobic exercise
Eligibility Criteria
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.
Sites / Locations
- National heart institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerobic and resistance training
Aerobic training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
six minute walking distance (in meters)
represent aerobic capacity (distance walked in 6 min)
P-R interval (in milliseconds)
represent a mortality index (the time from the beginning of atrial depolarization to the onset of ventricular depolarization) on the electrocardiograph
Secondary Outcome Measures
Full Information
NCT ID
NCT05846386
First Posted
April 26, 2023
Last Updated
April 26, 2023
Sponsor
Cairo University
Collaborators
RMIT University, Melbourne, Australia, Federation University Australia
1. Study Identification
Unique Protocol Identification Number
NCT05846386
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
RMIT University, Melbourne, Australia, Federation University Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valve Disease, Heart
Keywords
post valve replacement, resistance exercise, aerobic exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic and resistance training
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Aerobic training
Intervention Description
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.
Primary Outcome Measure Information:
Title
six minute walking distance (in meters)
Description
represent aerobic capacity (distance walked in 6 min)
Time Frame
4 weeks
Title
P-R interval (in milliseconds)
Description
represent a mortality index (the time from the beginning of atrial depolarization to the onset of ventricular depolarization) on the electrocardiograph
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hady Atef, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National heart institute
City
Giza
State/Province
Cairo
ZIP/Postal Code
11262
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After approval can be shared
IPD Sharing Time Frame
after 1 month for 12 months
IPD Sharing Access Criteria
will upload it to the journal of publication
Learn more about this trial
Early Resistance Training Post Valve Replacement Surgery
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