Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRV biofeedback.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis
Overview
This is a prospective interventional study exploring the modifiability of physiological metrics, namely Heart Rate Variability (HRV), using a 5-week standardized HRV biofeedback intervention in subjects with symptomatic ulcerative colitis. Participants will be followed for 17 weeks. The goal is the understand if modifying these markers can impact ulcerative colitis related symptoms.
Interventions
- Behavioral HRV biofeedback
An HRV biofeedback tool will be employed and utilized by individuals each day for the first 5 weeks during the intervention period.
Primary outcome measures
- Irritable Bowel Syndrome Symptom Severity Scale Score [Time frame: at end of Week 5]
Eligibility criteria
Inclusion criteria
- Adult subjects (18-65 years old)
- Ulcerative colitis with a symptomatic flare (SCCAI ≥3) and without inflammation (FC<250µg/ml)
Exclusion criteria
- Individuals who take medications known to alter heart rate variability
- Individuals with pacemakers or other implantable devices
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05892159 · STUDY-21-00870