Pacemaker DDDNCT04957771
Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation
A study testing Supervise and guide regular exercise in people with Pacemaker DDD and Cardiopulmonary Endurance, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe the changes of cardiopulmonary endurance in patients with pacemaker implantation after long-term exercise, to explore the significance of exercise on patients with pacemaker implantation, and to analyze the difference of the effect of exercise on cardiopulmonary endurance in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pacemaker DDD, Cardiopulmonary Endurance
- What is being tested?
- Supervise and guide regular exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Jul 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old patients with pacemaker implantation for the first time,
- 3-6 months after operation
- stable condition,
- independent walking ability.
Who cannot join
- Cognitive impairment;
- ICD, CRT / Crtd implanted,
- patients with neurogenic syncope;
- Atrial tachycardia, atrial fibrillation,
- NYHA class II or above,
- difficult to control hypertension;
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- Musculoskeletal disease limiting activity
- nervous system disease,
- severe respiratory disease,
- Patients with acute inflammation,
- cancer and other diseases uncontrolled.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to observe the changes of cardiopulmonary endurance in patients with pacemaker implantation after long-term exercise, to explore the significance of exercise on patients with pacemaker implantation, and to analyze the difference of the effect of exercise on cardiopulmonary endurance in patients with normal LVEF of different pacing ratios
- Conditions
- Pacemaker DDD, Cardiopulmonary Endurance
- Being tested
- Supervise and guide regular exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervise and guide regular exerciseOther
Aerobic exercise, evaluated by cardiopulmonary exercise test, 3-5 times a week
| Study group | Role | What they receive |
|---|---|---|
| Regular exercise group | Experimental | Not described Receives: Other: Supervise and guide regular exercise |
| non-regurlar exercise group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters related to exercise cardiopulmonary assessment
VO2peak
Measured: followed up for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Aug 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker DDDStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lijie sun, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957771
- Sponsor's protocol ID
- LM2019185
- Status last verified
- Aug 2019
- First submitted
- 27 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- 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 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation
- ClinicalTrials.gov ID
- NCT04957771
- Acronym / sponsor ID
- LM2019185
- Conditions
- Pacemaker DDD, Cardiopulmonary Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 12 Jul 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.
The purpose of this study is to observe the changes of cardiopulmonary endurance in patients with pacemaker implantation after long-term exercise, to explore the significance of exercise on patients with pacemaker implantation, and to analyze the difference of the effect of exercise on cardiopulmonary endurance in patients with normal LVEF of different pacing ratios
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular exercise group | Experimental | Other: Supervise and guide regular exercise |
| non-regurlar exercise group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old patients with pacemaker implantation for the first time,
- 3-6 months after operation
- stable condition,
- independent walking ability.
Key exclusion criteria (11 listed)
- Cognitive impairment;
- ICD, CRT / Crtd implanted,
- patients with neurogenic syncope;
- Atrial tachycardia, atrial fibrillation,
- NYHA class II or above,
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 |
|---|---|---|
| Supervise and guide regular exerciseAerobic exercise, evaluated by cardiopulmonary exercise test, 3-5 times a week | Other | Regular exercise group |
Primary outcome
Parameters related to exercise cardiopulmonary assessment
Time frame: followed up for one year
VO2peak
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 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Left Bundle Branch Area Mapping for Conduction System Pacing
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The Leadless AV Versus DDD Pacing Study
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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.
lijie sun, MD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervise and guide regular exercise in people with Pacemaker DDD and Cardiopulmonary Endurance, run by Peking University Third Hospital at 1 site in China.
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 11 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 12 Jul 2021. 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 China. 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?
Parameters related to exercise cardiopulmonary assessment (time frame: followed up for one year). 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 12 Jul 2021.