The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome

NCT ID: NCT05554107

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2028-10-31

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.

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.

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A - Supervised exercise first

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.

Group Type: ACTIVE_COMPARATOR

Training program

Intervention Type: 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 B - Self-instruction exercise first

See above.

Group Type: ACTIVE_COMPARATOR

Training program

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Viktor Hamrefors, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

Skånes Universitetssjukhus Malmö, Department of Cardiology

Malmo, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Isabella Kharraziha, MD

Role: CONTACT

isabella.kharraziha@med.lu.se

+46702941194

Viktor Hamrefors, MD, PhD

Role: CONTACT

viktor.hamrefors@med.lu.se

+46703996529

Facility Contacts

Isabella Kharraziha, MD

Role: primary

isabella.kharraziha@med.lu.se

+46702941194

Viktor Hamrefors, MD, PhD

Role: backup

viktor.hamrefors@med.lu.se

References

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Reference Type: BACKGROUND

PMID: 15699447 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 40588382 (View on PubMed)

Other Identifiers

POTS-phys

Identifier Type: -

Identifier Source: org_study_id