Valve Disease, HeartNCT05846386
Early Resistance Training Post Valve Replacement Surgery
A study testing Resistance training and Aerobic training in people with Valve Disease, Heart, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Valve Disease, Heart
- What is being tested?
- Resistance training and Aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Early Resistance Training on Functional Capacity and Electrocardiographic Changes Post Valve Replacement Surgery
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.
Read the 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
- Being tested
- Resistance training, Aerobic training
- Keywords
- post valve replacement, resistance exercise, aerobic exercise
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute walking distance (in meters)
represent aerobic capacity (distance walked in 6 min)
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Apr 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Disease, HeartStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- RMIT University, Melbourne, Australia, Federation University Australia
- Responsible party
- Principal investigator, Hady Atef Labib, Cairo University
- Investigators
- Hady Atef, Ph.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846386
- Sponsor's protocol ID
- post valve replacement
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After approval can be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Resistance Training on Functional Capacity and Electrocardiographic Changes Post Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT05846386
- Acronym / sponsor ID
- post valve replacement
- Conditions
- Valve Disease, Heart
- Keywords
- post valve replacement, resistance exercise, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- RMIT University, Melbourne, Australia, Federation University Australia
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic and resistance training | Experimental | Behavioral: Resistance training, Behavioral: Aerobic trainingaerobic 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 training | Active comparator | Behavioral: Aerobic trainingaerobic 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. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- The study excluded the participant if has one or more of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingmoderate-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 | Behavioural | Aerobic and resistance training |
| Aerobic trainingThe 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. | Behavioural | Aerobic and resistance training, Aerobic training |
Primary outcome
six minute walking distance (in meters)
Time frame: 4 weeks
represent aerobic capacity (distance walked in 6 min)
P-R interval (in milliseconds)
Time frame: 4 weeks
represent a mortality index (the time from the beginning of atrial depolarization to the onset of ventricular depolarization) on the electrocardiograph
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Yes. After approval can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hady Atef, Ph.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training and Aerobic training in people with Valve Disease, Heart, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six minute walking distance (in meters) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.