Muscular and Cutaneous Dysfunction in POTS

March 5, 2025 updated by: Insel Gruppe AG, University Hospital Bern

Muscular and Cutaneous Dysfunction in Postural Tachycardia Syndrome

POTS patients seem to experience orthostasis-dependent muscle weakness and pain as well as increased muscle fatigue upon physical activity, which can be improved by regular aerobic exercise. However, reduced sweat production of the extremities with limited control of the body temperature leads to exercise intolerance, so that sticking to a training program becomes a challenge for most patients. Recordings of MVRCs provide a new tool to assess muscle membrane dysfunction, depending on ischemia, surface temperature and training. As muscle dysfunction is assumed to be present in the majority of POTS patients but has not yet been scientifically studied the present study aims at understanding the muscular and cutaneous functioning in POTS using MVRC recordings, dependent both on orthostatic stress and exercise training as well as body temperature regulation. Our main hypothesis is that POTS patients experience functional muscle dysfunction that may be linked to altered muscle perfusion or body temperature regulation.

The purpose of this study is to examine muscular and cutaneous dysfunction in POTS in order to i) better understand the underlying pathology for symptoms and to ii) ultimately improve treatment options.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

POTS patients seem to experience orthostasis-dependent muscle weakness and pain as well as increased muscle fatigue upon physical activity, which can be improved by regular aerobic exercise. However, reduced sweat production of the extremities with limited control of the body temperature leads to exercise intolerance, so that sticking to a training program becomes a challenge for most patients. Recordings of MVRCs provide a new tool to assess muscle membrane dysfunction, depending on ischemia, surface temperature and training. As muscle dysfunction is assumed to be present in the majority of POTS patients but has not yet been scientifically studied the present study aims at understanding the muscular and cutaneous functioning in POTS using MVRC recordings, dependent both on orthostatic stress and exercise training as well as body temperature regulation. Our main hypothesis is that POTS patients experience functional muscle dysfunction that may be linked to altered muscle perfusion or body temperature regulation.

The purpose of this study is to examine muscular and cutaneous dysfunction in POTS in order to i) better understand the underlying pathology for symptoms and to ii) ultimately improve treatment options.

The study includes two examination days with the same procedure for all participants. In between the examination days, participants will undergo an endurance training protocol for 14 days. The first examination day takes place in two parts: Participants will first receive repetitive MVRC recordings of the right tibialis anterior muscle (TA): 1) before, during and after repetitive stimulation of the right TA (intermittent 20Hz for 10 min) in the supine position. Then MVRC recordings will be done from the left TA 2) in the supine position and during the 60° HUT upright position for 10 minutes. The duration of this first part is approximately 60 minutes. The second part consists of a TST of the hands and feet only, including a SWT on the index, middle and ring finger of both hands. This second part also lasts about 60 minutes. On the second examination day, the first part (only 1)) of the first examination day will be repeated. In between the examination days training sessions will be undertaken on days 1, 3, 5, 7, 9 and 11 between the examination days. Participants will be asked to contract their TA muscle repeatedly by pulling the right foot towards the head in a standing position while the heel remains on the ground (at 5 second intervals). In order to carry out the training they will also receive a video demonstrating the exercise. On days 1 and 3 they will do the exercise for 5 minutes, on days 5 and 7 for 10 minutes and on days 9 and 11 for 15 minutes.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria Patients:

  • Informed consent as documented by signature
  • Patients with diagnosed neuropathic POTS
  • Age: ≥18 years and ≤ 60 years

Inclusion Criteria Healthy Volunteers:

  • Informed consent as documented by signature
  • Age: ≥18 years and ≤ 60 years

Exclusion Criteria Patients:

  • Pregnancy and breastfeeding
  • Inability to adhere to the training protocol

Exclusion Criteria Healthy Volunteers:

  • Pregnancy and breastfeeding
  • Intake of vasoactive medication or known, non-treated arterial hypertension
  • Inability to adhere to the training protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients and Healthy volunteers
Patients and Healthy volunteers will undergo a 14-day training protocol. No study drugs will be administered. Patients and Healthy volunteers will be instructed regarding their training protocol. Training sessions will be undertaken on days 1, 3, 5, 7, 9 and 11 after the first examination day. Participants will be asked to contract their TA muscle repeatedly by pulling the right foot towards the head in a standing position while the heel remains on the ground (at 5 second intervals). In order to carry out the training they will also receive a video demonstrating the exercise. On days 1 and 3 they will do the exercise for 5 minutes, on days 5 and 7 for 10 minutes and on days 9 and 11 for 15 minutes.
Other: Patient and Healthy Volunteers training protocol
Patients and Healthy Volunteers will undergo a 14-day endurance training protocol. No study drugs will be administered. Patients and Healthy Volunteers will be instructed regarding their training protocol. Training sessions will be undertaken on days 1, 3, 5, 7, 9 and 11 after the first examination day. Patients and Healthy Volunteers will be asked to contract their TA muscle repeatedly by pulling the right foot towards the head in a standing position while the heel remains on the ground (at 5 second intervals). In order to carry out the training they will also receive a video demonstrating the exercise. On days 1 and 3 they will do the exercise for 5 minutes, on days 5 and 7 for 10 minutes and on days 9 and 11 for 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of early supernormality in%
Time Frame: Day 14
Change of early super normality as the most important parameter of MVRC measurements during HUT and fatigue in patients with neuropathic POTS compared to healthy subjects.
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of relative refractory period in msec
Time Frame: Day 14
During HUT and muscle fatigue
Day 14
Change of late supernormality period in %
Time Frame: Day 14
During HUT and muscle fatigue
Day 14
Change of early supernormality % after Muscle endurance training
Time Frame: Day 14
Muscle endurance training induced changes of MVRC measurements
Day 14
Change of relative refractory period in msec after Muscle endurance training
Time Frame: Day 14
Muscle endurance training induced changes of MVRC measurements
Day 14
Change of late supernormality in % after Muscle endurance training
Time Frame: Day 14
Muscle endurance training induced changes of MVRC measurements
Day 14
Area of palmar sweat production (in cm2)
Time Frame: Day 1
Qualitative sweat production
Day 1
Area of plantar sweat production (in cm2)
Time Frame: Day 1
Qualitative sweat production
Day 1
Skin wrinkling grade
Time Frame: Day 1
Skin wrinkling grade
Day 1
Intramuscular and skin temperature change
Time Frame: Day 14
Intramuscular and skin temperature changes during HUT and fatigue
Day 14
Recapillarization time at the lower extremities
Time Frame: Day 14
Recapillarization time at the lower extremities before and during HUT
Day 14
Heart rate changes
Time Frame: Day 14
Heart rate changes during HUT and fatigue
Day 14
Blood pressure changes
Time Frame: Day 14
Blood pressure changes during HUT and fatigue
Day 14
Maximal Tibialis Anterior peak force and endurance time
Time Frame: Day 14
Maximal Tibialis Anterior peak force and endurance time before and after training
Day 14
Circumference of the lower legs
Time Frame: Day 14
Circumference of the lower legs before and after training
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

  • Principal Investigator: Werner Z'Graggen, MD, Inselspital Bern, Department of Neurosurgery & Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Actual)

March 3, 2025

Study Completion (Actual)

March 3, 2025

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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