Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study

NCT04425785 | Completed

• 1 other identifier: 2-115-18
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Takotsubo Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Cardiac Energetics

  Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy

  Within three weeks after diagnosis

• Cardiac Energetics

  Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy

  At completion of 12 weeks intervention

Secondary Outcomes (6)

• Left Ventricular Global Longitudinal Strain

  Within three weeks after diagnosis

• Left Ventricular Global Longitudinal Strain

  At completion of 12 weeks intervention

• Exercise Capacity

  Within three weeks after diagnosis

• Exercise Capacity

  At completion of 12 weeks intervention

• Mental status and Stress

  Within three weeks after diagnosis

Study Arms (3)

Physical Exercise Group

EXPERIMENTAL

A structured exercise program for 12 weeks

Other: Physical Exercise Program

Cognitive Behavioural Therapy

EXPERIMENTAL

Cognitive Behavioural Therapy for 12 weeks

Behavioral: Cognitive Behavioural Therapy

Standard Clinical Care

NO INTERVENTION

Standard Clinical Care

Interventions

Physical Exercise Program OTHER

A structured exercise program

Physical Exercise Group

Cognitive Behavioural Therapy BEHAVIORAL

A structured cognitive behavioural therapy program

Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead
• British Heart Foundation: collaborator

Study Sites (1)

Cardiac Research Facility

Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom

Location

Related Publications (35)

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  PMID: 41332388 DERIVED

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dana Dawson, MPhil

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled study. Takotsubo patients will be randomised into one of the following groups: Exercise Arm Cognitive Behavioural Arm Standard Clinical Care

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 11, 2020
• Study Start: March 1, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)