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Muscular and Cutaneous Dysfunction in POTS

Muscular and Cutaneous Dysfunction in Postural Tachycardia Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04170725
Enrollment
15
Registered
2019-11-20
Start date
2020-01-10
Completion date
2025-03-03
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postural Tachycardia Syndrome

Keywords

POTS

Brief summary

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.

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.

Interventions

OTHERPatient 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.

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of early supernormality in%Day 14Change 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

MeasureTime frameDescription
Change of late supernormality period in %Day 14During HUT and muscle fatigue
Change of early supernormality % after Muscle endurance trainingDay 14Muscle endurance training induced changes of MVRC measurements
Change of relative refractory period in msec after Muscle endurance trainingDay 14Muscle endurance training induced changes of MVRC measurements
Change of late supernormality in % after Muscle endurance trainingDay 14Muscle endurance training induced changes of MVRC measurements
Area of palmar sweat production (in cm2)Day 1Qualitative sweat production
Area of plantar sweat production (in cm2)Day 1Qualitative sweat production
Change of relative refractory period in msecDay 14During HUT and muscle fatigue
Intramuscular and skin temperature changeDay 14Intramuscular and skin temperature changes during HUT and fatigue
Recapillarization time at the lower extremitiesDay 14Recapillarization time at the lower extremities before and during HUT
Heart rate changesDay 14Heart rate changes during HUT and fatigue
Blood pressure changesDay 14Blood pressure changes during HUT and fatigue
Maximal Tibialis Anterior peak force and endurance timeDay 14Maximal Tibialis Anterior peak force and endurance time before and after training
Circumference of the lower legsDay 14Circumference of the lower legs before and after training
Skin wrinkling gradeDay 1Skin wrinkling grade

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026