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The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome (POTS)

Primary Purpose

POTS - Postural Orthostatic Tachycardia Syndrome

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Training program
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for POTS - Postural Orthostatic Tachycardia Syndrome focused on measuring Exercise, POTS, Training programme, Treatment, Orthostatic intolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Skånes Universitetssjukhus Malmö, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A - Supervised exercise first

Group B - Self-instruction exercise first

Arm Description

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.

See above.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
Orthostatic tests
Hemodynamic measurements (pulse reaction) during orthostatic testing
Maximal biking exercise
Physical capacity measured in watts

Full Information

First Posted
September 21, 2022
Last Updated
December 15, 2022
Sponsor
Lund University
Collaborators
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT05554107
Brief Title
The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome
Acronym
POTS
Official Title
The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
POTS - Postural Orthostatic Tachycardia Syndrome
Keywords
Exercise, POTS, Training programme, Treatment, Orthostatic intolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - Supervised exercise first
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B - Self-instruction exercise first
Arm Type
Active Comparator
Arm Description
See above.
Intervention Type
Other
Intervention Name(s)
Training program
Intervention Description
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 Measure Information:
Title
POTS questionnaire
Description
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 months
Secondary Outcome Measure Information:
Title
Orthostatic hypotension questionnaire
Description
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 months
Title
SF-36
Description
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 months
Title
Orthostatic tests
Description
Hemodynamic measurements (pulse reaction) during orthostatic testing
Time Frame
12 months
Title
Maximal biking exercise
Description
Physical capacity measured in watts
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktor Hamrefors, MD, PhD
Organizational Affiliation
Department of Clinical Sciences, Lund University; Department of Cardiology Skåne University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Skånes Universitetssjukhus Malmö, Department of Cardiology
City
Malmö
ZIP/Postal Code
214 28
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15699447
Citation
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.
Results Reference
background
PubMed Identifier
20579544
Citation
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.
Results Reference
background
PubMed Identifier
26690066
Citation
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.
Results Reference
background
PubMed Identifier
22641777
Citation
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.
Results Reference
background
PubMed Identifier
32750291
Citation
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.
Results Reference
background
PubMed Identifier
36111700
Citation
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.
Results Reference
background
PubMed Identifier
26446970
Citation
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.
Results Reference
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The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome

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