The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome

NCT05554107 | Recruiting

• 1 other identifier: POTS-phys
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Keywords

Exercise; POTS; Training programme; Treatment; Orthostatic intolerance

Outcome Measures

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.

  12 months

Secondary Outcomes (4)

• Orthostatic hypotension questionnaire

  12 months

• SF-36

  12 months

• Orthostatic tests

  12 months

• Maximal biking exercise

  12 months

Study Arms (2)

Group A - Supervised exercise first

ACTIVE COMPARATOR

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. Results from questionnaires, orthostatic tests and maximal biking tests will be compared between group A and B as well as within each group.

Other: Training program

Group B - Self-instruction exercise first

ACTIVE COMPARATOR

See above.

Other: Training program

Interventions

Training program OTHER

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.

Group A - Supervised exercise first; Group B - Self-instruction exercise first

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with POTS who have given written informed consent for participation in the study.

You may not qualify if:

• Patients with myalgic encephalomyelitis are excluded from the study.

Sponsors & Collaborators

• Lund University: lead
• Region Skane: collaborator

Study Sites (1)

Skånes Universitetssjukhus Malmö, Department of Cardiology

Malmo, 214 28, Sweden

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Motor Activity; Orthostatic Intolerance

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Viktor Hamrefors, MD, PhD

  Department of Clinical Sciences, Lund University; Department of Cardiology Skåne University Hospital

  STUDY DIRECTOR

Central Study Contacts

Isabella Kharraziha, MD

CONTACT

+46702941194; isabella.kharraziha@med.lu.se

Viktor Hamrefors, MD, PhD

CONTACT

+46703996529; viktor.hamrefors@med.lu.se

Study Design

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

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: November 2, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)