CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Patient and Healthy Volunteers training protocolother
Likely dose
Not stated in record
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Search/NCT04170725
NCT04170725N/ACompleted

Muscular and Cutaneous Dysfunction in Postural Tachycardia Syndrome

Insel Gruppe AG, University Hospital Bern·interventional·Posted Nov 20, 2019·Updated Mar 10, 2025

In Brief

A clinical study evaluating Patient and Healthy Volunteers training protocol for Postural Tachycardia Syndrome. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 20, 2019
Enrollment StartJan 10, 2020
Primary CompletionMar 3, 2025
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 6.6 years ago

Interventions

Patient and Healthy Volunteers training protocolother

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.