The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Training program.
- Who it may be relevant to
- Registry conditions: POTS - Postural Orthostatic Tachycardia Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
A total of 200 patients diagnosed with POTS are asked to participate in the study. The study will be conducted as a cross over study. All POTS patients will continuously be randomized into two groups (Group A and B). Group A will first start the training program and when the training program is finished group B will start the training program. While each group is not performing the training program the patients will be encouraged to physical activity according to their own abilities.
Prior to start of the training program a special POTS questionnaire, the orthostatic hypotension questionnaire and SF-36 (general health questionnaire) will be completed by the participants. Orthostatic tests are performed during 10 minutes, measuring heart rate and blood pressure after 0, 1, 3, and, if possible, 10 minutes of standing. On a separate occasion, patients will perform a maximal biking exercise test, while noting symptoms, degree of exertion, achieved effect, pulse and blood pressure reaction. Following this initial evaluation, the training program will be performed during a total time of 16 weeks, which may be non-consecutive but within 6 months in total. The training program consists of 2-3 visits per week, and 60 minutes per visit. The training may be performed on specialized exercise bicycles in supine position or upright position depending on the severity of POTS symptoms. These exercises will be done under the supervision of physiotherapists with special interest in POTS. After the final training session the POTS questionnaire, the orthostatic hypotension questionnaire and SF-36 will be completed once again. In addition, orthostatic tests and maximal biking exercise test will be performed on a separate occasion soon after the last training session. The POTS questionnaire, the orthostatic hypotension questionnaire, SF-36, hemodynamics and exercise capacity will be compared before and after the 16-weeks training program.
Interventions
- Other Training program
A 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.
Primary outcome measures
- POTS questionnaire [Time frame: 12 months]
Secondary outcome measures (4)
- Orthostatic hypotension questionnaire [Time frame: 12 months]
- SF-36 [Time frame: 12 months]
- Orthostatic tests [Time frame: 12 months]
- Maximal biking exercise [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with POTS who have given written informed consent for participation in the study.
Exclusion criteria
- Patients with myalgic encephalomyelitis are excluded from the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Skånes Universitetssjukhus Malmö, Department of Cardiology — Malmö
Publications
- Winker R, Barth A, Bidmon D, Ponocny I, Weber M, Mayr O, Robertson D, Diedrich A, Maier R, Pilger A, Haber P, Rudiger HW. Endurance exercise training in orthostatic intolerance: a randomized, controlled trial. Hypertension. 2005 Mar;45(3):391-8. doi: 10.1161/01.HYP.0000156540.25707.af. Epub 2005 Feb 7. PMID 15699447
- Fu Q, Vangundy TB, Galbreath MM, Shibata S, Jain M, Hastings JL, Bhella PS, Levine BD. Cardiac origins of the postural orthostatic tachycardia syndrome. J Am Coll Cardiol. 2010 Jun 22;55(25):2858-68. doi: 10.1016/j.jacc.2010.02.043. PMID 20579544
- George SA, Bivens TB, Howden EJ, Saleem Y, Galbreath MM, Hendrickson D, Fu Q, Levine BD. The international POTS registry: Evaluating the efficacy of an exercise training intervention in a community setting. Heart Rhythm. 2016 Apr;13(4):943-50. doi: 10.1016/j.hrthm.2015.12.012. Epub 2015 Dec 9. PMID 26690066
- Shibata S, Fu Q, Bivens TB, Hastings JL, Wang W, Levine BD. Short-term exercise training improves the cardiovascular response to exercise in the postural orthostatic tachycardia syndrome. J Physiol. 2012 Aug 1;590(15):3495-505. doi: 10.1113/jphysiol.2012.233858. Epub 2012 May 28. PMID 22641777
- Kharraziha I, Axelsson J, Ricci F, Di Martino G, Persson M, Sutton R, Fedorowski A, Hamrefors V. Serum Activity Against G Protein-Coupled Receptors and Severity of Orthostatic Symptoms in Postural Orthostatic Tachycardia Syndrome. J Am Heart Assoc. 2020 Aug 4;9(15):e015989. doi: 10.1161/JAHA.120.015989. Epub 2020 Jul 30. PMID 32750291
- Spahic JM, Hamrefors V, Johansson M, Ricci F, Melander O, Sutton R, Fedorowski A. Malmo POTS symptom score: Assessing symptom burden in postural orthostatic tachycardia syndrome. J Intern Med. 2023 Jan;293(1):91-99. doi: 10.1111/joim.13566. Epub 2022 Sep 16. PMID 36111700
- Laucis NC, Hays RD, Bhattacharyya T. Scoring the SF-36 in Orthopaedics: A Brief Guide. J Bone Joint Surg Am. 2015 Oct 7;97(19):1628-34. doi: 10.2106/JBJS.O.00030. PMID 26446970
- Kharraziha I, Zulj R, Holm H, Fedorowski A, Hamrefors V. Assessing symptom improvement in patients with postural orthostatic tachycardia syndrome (POTS) following a 16-week structured exercise programme: a protocol for a randomised cross-over trial in a clinical outpatient setting. BMJ Open. 2025 Jun 30;15(6):e097057. doi: 10.1136/bmjopen-2024-097057. PMID 40588382
Identifiers
NCT: NCT05554107 · POTS-phys