Postural orthostatic tachycardia syndrome Circulatory System
Conditions
Interventions
Current interventions as of 25/10/2021:
Setting: Existing, fully equipped NHS Trust community cardiac rehabilitation centres with access to emergency equipment, and qualified/experienced staff and at
our intervention is based on existing evidence, our PPI and co-production sessions, and our centres’ expertise in the provision of exercise for clinical populations, including some pilot work in POTS.
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
Coventry University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 02/03/2022: 1. Aged 18 to 60 years 2. Confirmed diagnosis of POTS, and currently attending syncope out-patient clinics 3. Able to attend a PULSE centre 3 times over 7 months for outcomes assessments 4. Access to appropriate IT infrastructure at home – internet and internet-enabled device (device can be provided on loan if required) 5. Able to provide informed consent Previous participant inclusion criteria from 11/06/2021 to 02/03/2022: 1. Aged 18 to 40 years 2. Confirmed diagnosis of POTS, and currently attending syncope out-patient clinics 3. Able to attend a PULSE centre 3 times over 7 months for outcomes assessments 4. Access to appropriate IT infrastructure at home – internet and internet-enabled device (device can be provided on loan if required) 5. Able to provide informed consent Original participant inclusion criteria: 1. Adults 18 to 40 years of age 2. Confirmed diagnosis of POTS, and currently attending syncope out-patient clinics 3. Able to attend a PULSE centre 1-2 times/week for 8-12 weeks for exercise training 4. Able to provide informed consent
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 25/10/2021: 1. Absolute contraindications to exercise as per international clinical guidelines 2. Any serious mental health/cognitive issue that will prevent engagement with study procedures or increase the risk of exercise complications 3. Unable to make suitable travel arrangements to outcomes assessments (taxis can be organised if required) 4. Currently undertaking structured exercise/physical activity equivalent to meeting current Chief Medical Officer guidelines (150 minutes moderate exercise per week or 75 minutes vigorous per week) 5. Previous randomisation in the present trial 6. Pregnancy* 7. Taken part in the co-creation workshops to design the PULSE intervention *If a patient becomes pregnant during the study, they will be withdrawn from all the physical aspects (e.g. intervention, usual care, outcome measures) of the study. However, they can continue with the non-physical outcome measures if they wish. The researchers will not exclude people with: 1. Hypermobility spectrum disorders/Ehlers Danlos Syndrome (Classical or Hypermobile) 2. Chronic fatigue syndrome 3. Anxiety or depression Previous participant exclusion criteria from 11/06/2021 to 25/10/2021: 1. Absolute contraindications to exercise as per international clinical guidelines 2. Any serious mental health/cognitive issue that will prevent engagement with study procedures or increase the risk of exercise complications 3. Unable to make suitable travel arrangements to outcomes assessments (taxis can be organised if required) 4. Currently undertaking structured exercise/physical activity equivalent to meeting current Chief Medical Officer guidelines (150 minutes moderate exercise per week or 60 minutes vigorous per week) 5. Previous randomisation in the present trial 6. Pregnancy* 7. Taken part in the co-creation workshops to design the PULSE intervention *If a patient becomes pregnant during the study, they will be withdrawn from all the physical aspects (e.g. intervention, usual care, outcome measures) of the study. However, they can continue with the non-physical outcome measures if they wish. The researchers will not exclude people with: 1. Hypermobility spectrum disorders/Ehlers Danlos Syndrome (Classical or Hypermobile) 2. Chronic fatigue syndrome 3. Anxiety or depression Original participant exclusion criteria: 1. Absolute contraindications to exercise as per international clinical guidelines 2. Any serious mental health/cognitive issue that will prevent engagement with study procedures or increase the risk of exercise complications 3. Unable to make suitable travel arrangements 4. Currently undertaking structured exercise/physical activity equivalent to meeting current Chief Medical Officer guidelines (150 minutes moderate exercise per week or 60 minutes vigorous per week) 5. Previous randomisation in the present trial 6. Pregnancy* 7. Taken part in the co-creation workshops to design the PULSE intervention *If a patient becomes pregnant during the study, they will be withdrawn from all the physical aspects (e.g. intervention, usual care, outcome measures) of the study. However, they can continue with the non-physical outcome measures if they wish. The researchers will not exclude people with: 1. Hypermobility spectrum disorders/Ehlers Danlos Syndrome (Classical or Hypermobile) 2. Chronic fatigue syndrome 3. Anxiety or depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 11/06/2021: Feasibility and process-related outcomes: 1. Number of patients screened, eligible, recruited, randomised, withdrawn, and retained until the end of follow up at 7 months 2. Method of recruitment with which patients enter the trial 3. Adherence to exercise rehabilitation programme 4. Length of time to complete specific supervised and unsupervised outcome assessments 5. Physiological, clinical, patient-reported outcomes to identify a primary outcome for a definitive trial until the end of follow up at 7 months 6. Acceptability of the interventions and the trial assessed during qualitative interviews before and after the 12-week intervention period Previous primary outcome measure: Feasibility and process-related outcomes: 1. Number of patients screened, eligible, recruited, randomised, withdrawn and retained until the end of follow up at 7 months 2. Adherence to exercise rehabilitation programme after 12 weeks 3. Length of time to complete each outcome assessment and the whole outcome assessment appointments at 4 and 7 month follow-ups 4. Willingness of participants to join non-POTS specific exercise rehabilitation programmes during 12 months of recruitment 5. Physiological, clinical, patient-reported outcomes to identify a primary outcome for a definitive trial until the end of follow up at 7 months 6. Acceptability of the interventions and the trial assessed during qualitative interviews before and after the 12-week intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| Physiological, clinical and patient-reported outcomes: 1. Graded recumbent cycle ergometer test at baseline, 4 and 7 month follow-ups 2. Increase in heart rate from supine to 10-minute stand at baseline, 4 and 7 month follow-ups 3. Symptoms measured using COMPASS 31 dysautonomia scale at baseline, 4 and 7 month follow-ups 4. Quality of life measured using EQ5D-5L at baseline, 4 and 7 month follow-ups 5. Fatigue measured using Fatigue Severity Scale at baseline, 4 and 7 month follow-ups 6. Self-efficacy measured using General self-efficacy scale at baseline, 4 and 7 month follow-ups 7. Heart rate response to exercise measured by continuous heart rate monitoring during the 12-week exercise intervention 8. Symptoms experienced during the 12-week exercise intervention 9. Adverse events in accordance with GCP until the end of follow up at 7 months | — |
Countries
England, United Kingdom
Outcome results
None listed