Clinical trial

Compression Garments in the Community With POTS

Name
REB20-2224
Description
Compression Garments are a commonly prescribed treatment in Postural Orthostatic Tachycardia Syndrome (POTS). The effectiveness of a proof-of-concept compression garment has been demonstrated in an acute laboratory setting. It is not known if commercially available compression garments that participants wear in their every day lives are effective at improving heart rate and reducing symptoms in POTS. This trial will evaluate the use of commercially available waist-high and abdominal compression garments in adults diagnosed with POTS in a community setting.
Trial arms
Trial start
2021-05-17
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Treatment
Waist-High Compression Tights
Waist-high compression tights providing 15-40 mmHg of pressure.
Arms:
Waist-High Compression Tights and Medications, Waist-High Compression Tights and No Medications
Abdominal Compression Garments
Abdominal compression garment compressing the abdomen, buttocks, and upper thighs.
Arms:
Abdominal Compression Garments and Medications, Abdominal Compression Garments and No Medications
Other names:
Abdominal shapewear, compression shorts
Medications that modulate heart rate and blood pressure
Medications that modulate heart rate and blood pressure that participants regularly take. These medications include beta-blockers, midodrine, ivabradine and stimulants.
Arms:
Abdominal Compression Garments and Medications, Waist-High Compression Tights and Medications
Size
30
Primary endpoint
WHC Heart Rate
10 minutes
AC Heart Rate
10 minutes
Eligibility criteria
Inclusion Criteria: * Physician diagnosis of Postural Tachycardia Syndrome (POTS) * Resident of Canada * Owns waist-high compression garment: medical grade or commercially available tights with a pressure rating provided (e.g. 15-18 mmHg, 20-30 mmHg, 30-40 mmHg) * Optional Sub-Study: owns an abdominal compression garment (e.g. abdominal shapewear, waist high shorts) * Able to participate in a 4-day study (2x2 day segments with a 5-day washout period) Exclusion Criteria: * Overt cause for postural tachycardia (i.e., acute dehydration, thyroid disease) that precludes POTS diagnosis * Not a resident of Canada * Participants with somatization or severe anxiety symptoms will be excluded * Pregnant (self-reported) * Inability to tolerate compression garments for the duration of the study * Does not own a waist-high compression garment * Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study will investigate the effects waist high compression garments and medications compared to waist-high compression garments and medications held. Participants will cross-over and complete both arms. If participants participate in the abdominal compression sub-study, the order of waist-high compression - abdominal compression will also be randomized.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'It is not possible to mask participants to the compression garment intervention.'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-05-09

1 organization

1 product

1 indication