Physical Activity as a Complementary Treatment in POTS

NCT04702217 | Withdrawn

• 1 other identifier: PA-POTS
• Study Type: interventional
• Target: N/A
• 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

Keywords

Exercise; POTS; Training programme; Treatment; Orthostatic intolerance

Outcome Measures

Primary Outcomes (1)

• POTS questionnaire

  Subjective symptoms evaluated according to the POTS questionnaire.

  6 months

Secondary Outcomes (4)

• Orthostatic hypotension questionnaire

  6 months

• SF-36

  6 months

• Orthostatic tests

  6 months

• Submaximal biking exercise

  6 months

Study Arms (1)

POTS patients

EXPERIMENTAL

All POTS patients in the study will perform a 16 week-training program. The present study will be using longitudinal comparisons, meaning that the 100 POTS patients are their own controls. The questionnaires and exercise capacity will be compared before and after the 16-weeks training program.

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 with special interest in POTS.

POTS patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), 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

Study Sites (1)

Skånes Universitetssjukhus Malmö, Department of Cardiology

Malmo, Sweden

Location

Related Publications (5)

• 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

• Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available.

  PMID: 25980576 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Orthostatic Intolerance

Condition Hierarchy (Ancestors)

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

Study Officials

• Viktor Hamrefors, MD, PhD

  Department of Clinical Sciences, Malmö, Lund University, Malmö, Sweden and Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: October 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 6, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)