Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy

NCT05530135 | Completed

• 1 other identifier: 283639
• Study Type: interventional
• Target: 85
• 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. The purpose of this 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 result in significant improvement in the brain activity, general and mental wellbeing of patients.

Conditions

Takotsubo Cardiomyopathy

Keywords

Takotsubo Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Hippocampal volume change

  Brain Magnetic Resonance Imaging

  At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

Secondary Outcomes (5)

• Mental wellbeing testing

  At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

• Mental wellbeing testing

  At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

• Mental wellbeing test

  At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

• Exercise Capacity

  At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

• Cardiac Imaging

  At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Takotsubo patients receiving standard care

Other: Standard clinical care

Exercise Group

ACTIVE COMPARATOR

Takotsubo patients who will undergo an exercise program in addition to standard care

Other: Exercise program; Other: Standard clinical care

CBT Group

ACTIVE COMPARATOR

Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care

Other: Cognitive behavioural therapy; Other: Standard clinical care

Interventions

Exercise program OTHER

Exercise program

Exercise Group

Cognitive behavioural therapy OTHER

Cognitive behavioural therapy

CBT Group

Standard clinical care OTHER

Standard clinical care

CBT Group; Control Group; Exercise Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with takotsubo cardiomyopathy in the previous three weeks
• Participant who is willing and able to give informed consent for participation in the study.
• Participant who is willing to travel to Aberdeen Royal Infirmary for the study visits.
• Healthy volunteers (for blood and saliva samples only) willing to give informed consent for participation in the study. Healthy volunteers should not be on any medication.
• For influenza T-Cell testing: healthy volunteers who have recently received their annual flu vaccination.
• Myocardial Infarction (MI) comparators: patients with type 1 acute MI (diagnosed within the last three weeks)

You may not qualify if:

• Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them from taking part in a physical exercise training program
• Any patient who is not able or 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 or a treadmill (e.g. use of walking aids or prosthetic limbs or advanced frailty)
• Unwillingness to participate
• Contraindication to MRI scanning such as implantable cardiac devices.
• Pregnancy
• Healthy volunteers taking medication

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Interventions

Resistance Training; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

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

Model Details: Three arm pilot feasibility study

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 7, 2022
• Study Start: October 6, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

GB (1)