Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study
NCT ID: NCT04425785
Last Updated: 2023-12-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
76 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-03-01
Study Completion Date
2023-09-01
Brief Summary
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Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. Recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. Research conducted in our unit has found that the heart function does not recover fully as is commonly believed and that the energetic status of the heart remains impaired for an extended period of time. The purpose of our study is to establish whether following a structured exercise program or a mental wellbeing program compared to usual care for 12 weeks after an episode of Takotsubo will improve the energy status of the heart, their physical conditioning and improve the general mental wellbeing of patients.
Detailed Description
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Acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. The researchers have shown that recovery is more protracted than previously appreciated, and is associated with persistent major morbidity and a long-term heart failure phenotype. In the absence of any effective therapeutic options, the researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation (standardised physical exercise training or cognitive behavioural therapy) versus current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy. The primary end-point will be the restoration of cardiac energetic status assessed by 31P-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening response, global longitudinal strain by echocardiography and the 6-minute walk test. If successful, this has the potential for rapid implementation into a large randomised clinical trial.
Conditions
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Takotsubo Cardiomyopathy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomised controlled study. Takotsubo patients will be randomised into one of the following groups:
Exercise Arm Cognitive Behavioural Arm Standard Clinical Care
Exercise Arm Cognitive Behavioural Arm Standard Clinical Care
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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Physical Exercise Group
A structured exercise program for 12 weeks
Group Type
EXPERIMENTAL
Physical Exercise Program
Intervention Type
OTHER
A structured exercise program
Cognitive Behavioural Therapy
Cognitive Behavioural Therapy for 12 weeks
Group Type
EXPERIMENTAL
Cognitive Behavioural Therapy
Intervention Type
BEHAVIORAL
A structured cognitive behavioural therapy program
Standard Clinical Care
Standard Clinical Care
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Physical Exercise Program
A structured exercise program
Intervention Type
OTHER
Cognitive Behavioural Therapy
A structured cognitive behavioural therapy program
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* A patient who has recently suffered an episode of takotsubo cardiomyopathy within the last three weeks
* Participant who is willing and able to give informed consent for participation in the study.
* Participant who is willing and able to give informed consent for participation in the study.
Exclusion Criteria
* Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them for taking part in a physical exercise training program.
* Any patient who is not able or not willing to travel to the cardiovascular research facility for their study visits.
* Any patient who is not able to commit to a 12 week supervised training program.
* Inability to exercise on a cycle ergometer (i.e. use of walking aids or prosthetic limbs).
* Contraindication to magnetic resonance scanning such as an implantable cardiac device.
* Pregnancy
* Any patient who is not able or not willing to travel to the cardiovascular research facility for their study visits.
* Any patient who is not able to commit to a 12 week supervised training program.
* Inability to exercise on a cycle ergometer (i.e. use of walking aids or prosthetic limbs).
* Contraindication to magnetic resonance scanning such as an implantable cardiac device.
* Pregnancy
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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British Heart Foundation
OTHER
Sponsor Role
collaborator
University of Aberdeen
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Dana Dawson, MPhil
Role: PRINCIPAL_INVESTIGATOR
University of Aberdeen
Locations
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Cardiac Research Facility
Aberdeen, Aberdeenshire, United Kingdom
Site Status
Countries
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United Kingdom
References
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Other Identifiers
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2-115-18
Identifier Type: -
Identifier Source: org_study_id