Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac SurgeryNCT04903691
Changes in Fitness and Strength in Postoperative Cardiac Patients Undergoing Exercise Therapy: Biological and Functional Mechanisms of Recovery
A study testing Cardiac Exercise Program in people with Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac Surgery, run by Yale University at 1 site in United States.
Trial summary
This study seeks to determine the biological, physiological and psychological effects of supervised exercise programs in patients surviving open heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac Surgery
- What is being tested?
- Cardiac Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 30 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients at least 18 years of age or older who undergo open heart surgery and who intend to enroll in a cardiac rehabilitation program.
Who cannot join
- Patients may be excluded for inability to read or understand English
- suffering from a condition that precludes informed consent (for example, cardiogenic shock)
- hemodynamic instability
- ongoing trauma or substance overdoses
- known intellectual or developmental delay
- communication impairment
Show all 10Show fewer
- active users of illicit substances
- active psychiatric illness
- inability to attend cardiac rehabilitation (homeless, in police custody, or living out of state)
- inability to exercise (lower limb amputation, bedridden, decompensated heart failure, ongoing cancer treatment)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Church Street Research Unit (CSRU)
New Haven, Connecticut, 06511
About this study
This study seeks to determine the biological, physiological and psychological effects of supervised exercise programs in patients surviving open heart surgery.
Read the detailed description
Patients who have survived open heart surgery and cleared for exercise by their clinical team will be approached to enter a 12-week exercise program. Patient will consent to train with a personalized program either in strength, functional or aerobic exercise in a supervised setting for 3 sessions per week for a minimum of 12-week period. The aim is to enroll males and females in this arm in 1:1 ratio if possible. A separate cohort of patients entering cardiac rehabilitation (CR) will also be included for comparison. The CR program includes three sessions per week for a maximum of 36 sessions. The enrollment and retention rates in CR will be monitored. In this study, five patients who have undergone cardiac surgery and chosen not to participate in organized exercise program will be included. Participants cardiorespiratory fitness will be measured either using a questionnaire or in person. Through each phase of the study, the change in fitness, strength, biomarkers, body composition, cognition and psychosocial recovery will be monitored. All subjects will undergo detailed assessments in the research lab 2 weeks before and after finishing or exiting exercise program. A short (3-month) and long term (12-month) outcomes including rates of survival, major adverse cardiac events, cognition and cardiac-related hospitalizations will be collected as well during the study.
- Being tested
- Cardiac Exercise Program
- Keywords
- cardiorespiratory fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Exercise ProgramBehavioural
Participants who enrolled in cardiac exercise program
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | 130 patients who underwent open heart surgery and are cleared for exercise.These will include patients who enter supervised cardiac rehabilitation as well as patients who enter a supervised exercise program focusing strength training, endurance of functional training. Receives: Behavioral: Cardiac Exercise Program |
| Additional controls | No intervention | 5 patients who choose not to enter any organized exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness
Change in peak cardiorespiratory fitness as measured by metabolic equivalent (METS). (Higher values indicate higher fitness)
Measured: Baseline and 2 weeks after completing exercise program
Change in strength
Change in strength as measured by grip strength (Higher values indicate better strength).
Measured: Baseline and 2 weeks after completing exercise program
Change in functional fitness.
Change in functional fitness as measured by the Short Physical Performance Battery (higher overall score or less time to completion indicates higher fitness)
Measured: Baseline and 2 weeks after completing exercise program
Change in cognition
Measured by standardized tests of cognition such as Montreal Cognitive Assessment (MoCA) (Higher values indicate better cognition with scores less than 23-26 adjusting for education indicative of impaired cognition)
Measured: Baseline and 2 weeks after completing exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start15 May 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Yale 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention study with organized exercise program in intervention arm, no organized exercise in control arm
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Basmah Safdar, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903691
- Sponsor's protocol ID
- 2000028739
- Status last verified
- Jun 2023
- First submitted
- 21 May 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Fitness and Strength in Postoperative Cardiac Patients Undergoing Exercise Therapy: Biological and Functional Mechanisms of Recovery
- ClinicalTrials.gov ID
- NCT04903691
- Acronym / sponsor ID
- 2000028739
- Keywords
- cardiorespiratory fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 May 2021 (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.
This study seeks to determine the biological, physiological and psychological effects of supervised exercise programs in patients surviving open heart surgery.
Detailed description
Patients who have survived open heart surgery and cleared for exercise by their clinical team will be approached to enter a 12-week exercise program. Patient will consent to train with a personalized program either in strength, functional or aerobic exercise in a supervised setting for 3 sessions per week for a minimum of 12-week period. The aim is to enroll males and females in this arm in 1:1 ratio if possible. A separate cohort of patients entering cardiac rehabilitation (CR) will also be included for comparison. The CR program includes three sessions per week for a maximum of 36 sessions. The enrollment and retention rates in CR will be monitored. In this study, five patients who have undergone cardiac surgery and chosen not to participate in organized exercise program will be included. Participants cardiorespiratory fitness will be measured either using a questionnaire or in person. Through each phase of the study, the change in fitness, strength, biomarkers, body composition, cognition and psychosocial recovery will be monitored. All subjects will undergo detailed assessments in the research lab 2 weeks before and after finishing or exiting exercise program. A short (3-month) and long term (12-month) outcomes including rates of survival, major adverse cardiac events, cognition and cardiac-related hospitalizations will be collected as well during the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention study with organized exercise program in intervention arm, no organized exercise in control arm
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Cardiac Exercise Program130 patients who underwent open heart surgery and are cleared for exercise.These will include patients who enter supervised cardiac rehabilitation as well as patients who enter a supervised exercise program focusing strength training, endurance of functional training. |
| Additional controls | No intervention | –5 patients who choose not to enter any organized exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at least 18 years of age or older who undergo open heart surgery and who intend to enroll in a cardiac rehabilitation program.
Key exclusion criteria (10 listed)
- Patients may be excluded for inability to read or understand English
- suffering from a condition that precludes informed consent (for example, cardiogenic shock)
- hemodynamic instability
- ongoing trauma or substance overdoses
- known intellectual or developmental delay
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 |
|---|---|---|
| Cardiac Exercise ProgramParticipants who enrolled in cardiac exercise program | Behavioural | Exercise training |
Primary outcome
Change in cardiorespiratory fitness
Time frame: Baseline and 2 weeks after completing exercise program
Change in peak cardiorespiratory fitness as measured by metabolic equivalent (METS). (Higher values indicate higher fitness)
Change in strength
Time frame: Baseline and 2 weeks after completing exercise program
Change in strength as measured by grip strength (Higher values indicate better strength).
Change in functional fitness.
Time frame: Baseline and 2 weeks after completing exercise program
Change in functional fitness as measured by the Short Physical Performance Battery (higher overall score or less time to completion indicates higher fitness)
Change in cognition
Time frame: Baseline and 2 weeks after completing exercise program
Measured by standardized tests of cognition such as Montreal Cognitive Assessment (MoCA) (Higher values indicate better cognition with scores less than 23-26 adjusting for education indicative of impaired cognition)
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 9 Jun 2023.
- Individual participant dataSharing planned: Undecided
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.
Basmah Safdar, MD principal investigator
Yale 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 Cardiac Exercise Program in people with Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac Surgery, run by Yale University at 1 site in United States.
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 1 inclusion and 10 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 9 Jun 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 United States. 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?
Change in cardiorespiratory fitness (time frame: Baseline and 2 weeks after completing exercise program). The study lists 4 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 9 Jun 2023.