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Completed

NCT Number: NCT04170725

Muscular and Cutaneous Dysfunction in POTS

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient and Healthy Volunteers training protocol

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change of relative refractory period in msec

    Time frame: Day 14

    During HUT and muscle fatigue

  2. Change of late supernormality period in %

    Time frame: Day 14

    During HUT and muscle fatigue

  3. Change of early supernormality % after Muscle endurance training

    Time frame: Day 14

    Muscle endurance training induced changes of MVRC measurements

  4. Change of relative refractory period in msec after Muscle endurance training

    Time frame: Day 14

    Muscle endurance training induced changes of MVRC measurements

  5. Change of late supernormality in % after Muscle endurance training

    Time frame: Day 14

    Muscle endurance training induced changes of MVRC measurements

  6. Area of palmar sweat production (in cm2)

    Time frame: Day 1

    Qualitative sweat production

  7. Area of plantar sweat production (in cm2)

    Time frame: Day 1

    Qualitative sweat production

  8. Skin wrinkling grade

    Time frame: Day 1

    Skin wrinkling grade

  9. Intramuscular and skin temperature change

    Time frame: Day 14

    Intramuscular and skin temperature changes during HUT and fatigue

  10. Recapillarization time at the lower extremities

    Time frame: Day 14

    Recapillarization time at the lower extremities before and during HUT

  11. Heart rate changes

    Time frame: Day 14

    Heart rate changes during HUT and fatigue

  12. Blood pressure changes

    Time frame: Day 14

    Blood pressure changes during HUT and fatigue

  13. Maximal Tibialis Anterior peak force and endurance time

    Time frame: Day 14

    Maximal Tibialis Anterior peak force and endurance time before and after training

  14. Circumference of the lower legs

    Time frame: Day 14

    Circumference of the lower legs before and after training

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Muscular and Cutaneous Dysfunction in Postural Tachycardia Syndrome

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2019
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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