Early Resistance Training Post Valve Replacement Surgery

Valve Disease, Heart Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05846386
• Other study ID #: post valve replacement
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Diseases
• Valve Disease, Heart

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	National heart institute	Giza	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	Federation University Australia, RMIT University, Melbourne, Australia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	six minute walking distance (in meters)	represent aerobic capacity (distance walked in 6 min)	4 weeks
Primary	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	4 weeks