The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLund University
About this trial
Postural orthostatic tachycardia syndrome (POTS) is a disorder of unknown origin characterized by orthostatic intolerance and increased heart rate (HR) of ≥ 30 beats/minute during orthostasis in the absence of orthostatic hypotension. In addition to the orthostatic intolerance and tachycardia, patients with POTS experience several debilitating symptoms including light-headedness, nausea, blurred vision, fatigue, mental confusion ("brain-fog"), chest pain and gastrointestinal problems. Several potential underlying mechanisms have been suggested for POTS including autonomic denervation, hypovolemia, hyperadrenergic stimulation and autoantibodies against adrenergic receptors. However, none of these proposed mechanisms has yet led to an effective treatment. Physical activity is recommended as a complimentary treatment in POTS in international guidelines. However, less is known regarding how physical activity could successfully be implemented in clinical practice in patients with POTS. Thus, in the current study, we aim to assess the effect of a 16-week specialized physical activity program in POTS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with POTS who have given written informed consent for participation in the study.
Disqualifiers
Patients with myalgic encephalomyelitis are excluded from the study.
Trial design
Design model
Crossover
Treatments tested in this trial
Training program
Other interventionA 16-week training program consisting of 2-3 visits per week, and 60 minutes per visit. The program will be done as group exercise under supervision from physiotherapists and/or physicians with special interest in POTS.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Group A - Supervised exercise firstActive comparator 1 intervention
Group B: Group B - Self-instruction exercise firstActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
POTS questionnaire
Subjective symptoms evaluated according to the Malmö POTS Symptom Score which has previously been described (Spahic et al. 2022). The questionnaire is based on patients' own perception of 12 commonly reported symptoms: five cardiac symptoms (palpitations, dizziness, presyncope, dyspnoea and chest pain) and seven non-cardiac symptoms (gastrointestinal symptoms, insomnia, concentration difficulties, headache, myalgia, nausea and fatigue) during the previous 7 days, graded on a scale from 0 (no symptoms) to 10 (very pronounced symptoms). The score ranges from 0 to a maximum score of 120 points.
Time frame
12 monthsSecondary outcomes
1
Orthostatic hypotension questionnaire
Subjective symptoms evaluated according to the orthostatic hypotension questionnaire (OHQ). The OHQ is a questionnaire that has been previously validated and used for orthostatic hypotension but has also been used for quantification of POTS-related symptoms. Further details on the OHQ has previously been described in Kharraziha et al (2020).
Time frame
12 months2
SF-36
Evaluation of 36-item Short Form Health Survey (SF-36). The SF-36 is a 36-item patient-reported questionnaire covering eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Time frame
12 months3
Orthostatic tests
Hemodynamic measurements (pulse reaction) during orthostatic testing
Time frame
12 months4
Maximal biking exercise
Physical capacity measured in watts
Time frame
12 monthsSponsors and contacts
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Lund University
Lead sponsor
Region Skane
Collaborator
Source ClinicalTrials.gov