Early Resistance Training Post Valve Replacement Surgery

NCT05846386 | Completed DMC

• 1 other identifier: post valve replacement
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Valve Disease, Heart

Keywords

post valve replacement; resistance exercise; aerobic exercise

Outcome Measures

Primary Outcomes (2)

• six minute walking distance (in meters)

  represent aerobic capacity (distance walked in 6 min)

  4 weeks

• 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

Study Arms (2)

Aerobic and resistance training

EXPERIMENTAL

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; Behavioral: Aerobic training

Aerobic training

ACTIVE COMPARATOR

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

Interventions

Resistance training 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 and resistance training

Aerobic training 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 and resistance training; Aerobic training

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• RMIT University, Melbourne, Australia: collaborator
• Federation University Australia: collaborator

Study Sites (1)

National heart institute

Giza, Cairo Governorate, 11262, Egypt

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hady Atef, Ph.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physiotherapy for cardiovascular/respiratory disorders

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: April 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after 1 month for 12 months
• Access Criteria: will upload it to the journal of publication

Locations

EG (1)