Trial Outcomes & Findings for Behavioral Therapy in Patients With Rumination (NCT NCT05232097)
NCT ID: NCT05232097
Last Updated: 2024-11-18
Results Overview
Rumination score measured by question 32 of the Rome 4 diagnostic questionnaire for adult functional gastrointestinal disorders. The question scores the rumination frequency as follows: "In the last 3 months, how often did food come back up into your mouth after you swallowed it ?, 0 = never, 1= fewer than 1 day a month, 2 = 1 day a month, 3 = 2-3 days a month, 4 = 1 day a week, 5 = 2-3 days a week, 6 = most days, 7 = every day, 8 = multiple times per day or all the time". Scale 0-8, the highest score indicating highest frequency of rumination.
COMPLETED
NA
11 participants
6-month control
2024-11-18
Participant Flow
Participant milestones
| Measure |
Behavioral Therapy
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Behavioral Therapy
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
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|---|---|
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Behavioral Therapy in Patients With Rumination
Baseline characteristics by cohort
| Measure |
Behavioral Therapy
n=11 Participants
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
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|---|---|
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Age, Continuous
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38 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
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1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=39 Participants
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|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
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10 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
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Region of Enrollment
Finland
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11 participants
n=39 Participants
|
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Rumination score (self-perceived rumination frequency)
|
6.5 units on a scale
n=39 Participants
|
|
Anxiety score (BAI)
|
18 Units on a score
n=39 Participants
|
|
Depression score (BDI)
|
12 Score on scale
n=39 Participants
|
|
Healt-related quality of life (15D)
|
0.793 units on a scale
STANDARD_DEVIATION 0.171 • n=39 Participants
|
|
Functional capacity (WHODAS 2.0)
|
26 units on a scale
n=39 Participants
|
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Weight
|
71 kilograms
n=39 Participants
|
PRIMARY outcome
Timeframe: 6-month controlPopulation: The 10 patients who finished the study.
Rumination score measured by question 32 of the Rome 4 diagnostic questionnaire for adult functional gastrointestinal disorders. The question scores the rumination frequency as follows: "In the last 3 months, how often did food come back up into your mouth after you swallowed it ?, 0 = never, 1= fewer than 1 day a month, 2 = 1 day a month, 3 = 2-3 days a month, 4 = 1 day a week, 5 = 2-3 days a week, 6 = most days, 7 = every day, 8 = multiple times per day or all the time". Scale 0-8, the highest score indicating highest frequency of rumination.
Outcome measures
| Measure |
Behavioral Therapy
n=10 Participants
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
|
|---|---|
|
Rumination Score (Self-perceived Rumination Frequency)
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4 score on a scale
Interval 3.0 to 5.0
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SECONDARY outcome
Timeframe: 6-month controlPopulation: The 9 patients who were performed manometry at the 6-month control. Out of the 10 patients who finished the study, one refused.
Number of patients with abdominal pressure peaks of an amplitude of 30 mm Hg or higher measured by means of esophageal high-reselution manometry indicating rumination.
Outcome measures
| Measure |
Behavioral Therapy
n=9 Participants
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
|
|---|---|
|
Number of Patients With Abdominal Pressure Peaks of an Amplitude of 30 mmHg or Higher
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6 Participants
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SECONDARY outcome
Timeframe: 6-month controlPopulation: The 8 patients who returned the 15D-questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 did not return the questionnaire at the 6-month control.
The 15D, a 15-dimensional measure of health-related quality of life includes 15 dimensions: breathing, mental function, speech, vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression, each scored from 1 (best possible) to 0 (worst possible). The 15D score, a single index number calculated over all the dimensions, is ranged from the maximum score 1 (no problems on any dimension) to the minimum score 0 (being dead).
Outcome measures
| Measure |
Behavioral Therapy
n=8 Participants
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
|
|---|---|
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Health-related Quality of Life (15D)
|
0.845 units on a scale
Standard Deviation 0.141
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SECONDARY outcome
Timeframe: 6-month controlPopulation: The 8 patients who returned the WHODAS 2.0 questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 patients did not return the questionnaire at the 6-month control.
WHODAS 2.0, the WHO Disability Assessment Schedule 2.0 questionnaire, covers six domains of functioning, including: Cognition - understanding \& communicating, Mobility- moving \& getting around, Self-care- hygiene, dressing, eating \& staying alone, Getting along- interacting with other people, Life activities- domestic responsibilities, leisure, work \& school, and Participation- joining in community activities. Each domain is ranged from 0 (no disability) to 100 (full disability). The WHODAS 2.0 summary score consisting of all six domains is converted to metric ranging from 0 to 100, with 0 indicating no disability and 100 full disability.
Outcome measures
| Measure |
Behavioral Therapy
n=8 Participants
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
|
|---|---|
|
Functional Capacity (WHODAS 2.)
|
11 units on a scale
Interval 7.0 to 26.0
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SECONDARY outcome
Timeframe: 6-month controlPopulation: The 8 patients who returned the BDI-questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 did not return the questionnaire at the 6-month control.
Beck Depression Inventory (BDI) Score, scale 0-63. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Outcome measures
| Measure |
Behavioral Therapy
n=8 Participants
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
|
|---|---|
|
Depression Score (BDI)
|
7 score on a scale
Interval 4.0 to 8.0
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SECONDARY outcome
Timeframe: 6-month controlPopulation: The 8 patients who returned the BAI questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 did not return the questionnaire at the 6-month control.
Beck Anxiety Inventory (BAI) Score, scale 0-63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Outcome measures
| Measure |
Behavioral Therapy
n=8 Participants
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
|
|---|---|
|
Anxiety Score (BAI)
|
15 score on a scale
Interval 7.0 to 27.0
|
SECONDARY outcome
Timeframe: 6-month controlPopulation: All 10 patients who finished the study.
Weight in kilograms
Outcome measures
| Measure |
Behavioral Therapy
n=10 Participants
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy: Diaphragmatic breathing exercises
Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
|
|---|---|
|
Weight
|
71 kilogram
Interval 56.0 to 93.0
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Adverse Events
Behavioral Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place