Early Resistance Training Post Valve Replacement Surgery

NCT ID: NCT05846386

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-11-30

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)

Conditions

Valve Disease, Heart

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Aerobic training

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RMIT University, Melbourne, Australia

UNKNOWN

Sponsor Role: collaborator

Federation University Australia

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hady Atef Labib

Lecturer of physiotherapy for cardiovascular/respiratory disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hady Atef, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

National heart institute

Giza, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

post valve replacement

Identifier Type: -

Identifier Source: org_study_id