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The purpose of this research is to better understand constipation and improve biofeedback treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback and inspiratory muscle training (BFT Plus) | Experimental | Subjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes. In addition, subjects will engage in inspiratory muscle training (IMT) at home. |
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| Biofeedback only (BFT Alone) | Active Comparator | Subjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback | Behavioral | During anorectal biofeedback therapy, subjects are coached to improve abnormal patterns while observing activity recorded by manometry and/or surface EMG (electromyography) on a computer monitor while seated on a chair or a commode. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rectoanal gradient during evacuation | Rectoanal gradient during evacuation is the pressure difference between the rectum and the anal canal during simulated evacuation, measured in millimeters of mercury (mmHg). | Baseline, through study completion, an average of 16 weeks |
| Change in rectal pressure during evacuation | Rectal pressure during evacuation is the difference in rectal pressure during - before evacuation. Results are measured in millimeters of mercury (mmHg). | Baseline, through study completion, an average of 16 weeks |
| Change in balloon expulsion time | Rectal balloon expulsion directly assesses evacuation. Patients will be asked to expel a rectal balloon inflated up to 50 ml of water. The time required to expel the balloon will be measured and reported in seconds. | Baseline, through study completion, an average of 16 weeks |
| Change in rectal emptying time | Rectal emptying will be assessed via fecoflowmetry by measuring the time required to defecate (seconds) artificial stool from the rectum | Baseline, through study completion, an average of 16 weeks |
| Change in rectal emptying rate | Rectal emptying will be assessed via fecoflowmetry by measuring the amount (gm) of artificial stool from the rectum. The 2 metrics - amount and time - are integrated to measure amount (gm) evacuated per unit time (second) (gm/sec). | Baseline, through study completion, an average of 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire | The PAC-SYM questionnaire assesses the severity of patient-reported symptoms related to constipation. The questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden. Scores range from 0 to 48. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly J. Feuerhak, RN, CCRP | Contact | 507-255-6802 | feuerhak.kelly@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adil E. Bharucha, MBBS, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| Inspiratory muscle training (IMT) | Behavioral | Subjects will engage in inspiratory muscle training (IMT) that is tailored to the baseline performance of the individual. |
|
| Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion |
| Change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) questionnaire | The PAC-QOL questionnaire is a patient-reported outcome measure to evaluate quality of life in constipated persons. The questionnaire is divided into four subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Scale scores represent average item scores and range from 0 to 4, where higher scores represent poorer quality of life. Scores range from 0 to 112. | Baseline, through study completion, an average of 16 weeks, 3 months post completion , 12 months post completion |
| Physical Activity Rating Scale | Physical Activity Rating is a questionnaire for categorizing physical activity level, which is used in the equation for the non-exercise fitness test. The Physical Activity Rating is a score value between 0 to 7. The non-exercise fitness test of VO2max, a measure of cardiovascular fitness, will be calculated using the following equation: 56.363 + 1.921 (Physical Activity Rating) - 0.381(Age) - 0.754(Body Mass Index) + 10.987(Sex: 0 for women, 1 for men) | Baseline |
| Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire | Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 11-item questionnaire is a standardized tool to measure the satisfaction of an individual who is using an assistive device. It inquiries about the assistive device itself: dimensions, weight, ease of adjustment, safety, durability, ease of use, comfortability, and effectiveness; and service: service delivery, maintenance, professional services, and follow up services. Each question is answered on a Likert scale, where 1 = not satisfied at all, and 5 = very satisfied. Possible scores range from 11 to 55. | through study completion, an average of 16 weeks |
| Change in stool frequency | Daily number of bowel movements will be self-reported by participants via a bowel diary. | Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion |
| Change in stool consistency | Daily stool consistency will be self-reported by participants via a bowel diary by using the Bristol Stool Chart. Participants will compare stool's appearance to the 7 types and selecting the one that most closely matches. Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency. | Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion |
| Change in anal digitation | The total number of times anal digitation was required to achieve a bowel movement will be self-reported via the bowel diary. | Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion |
| Change in sense of incomplete evacuation | The total number of times a participant felt a sense of incomplete evacuation after a bowel movement will be self-reported via the bowel diary. | Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion |
| Change in spontaneous bowel movements | The total number of times a participant achieves a spontaneous bowel movement will be self-reported via the bowel diary. | Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion |
| Change in pain during bowel movements | Pain during bowel movements will be self-reported by participants via the bowel diary using a 4-point Likert scale (0 = None, 1 = Mild, 3 = Moderate, and 4 = Severe). | Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion |
| Change in bowel symptoms before and after biofeedback therapy | Bowel symptoms pre and post biofeedback therapy will be assessed using a self-reported questionnaire. The survey includes Severity of constipation, satisfaction with bowel movements, satisfaction with current treatment of constipation, severity of constipation compared to baseline, adequate relief of constipation, use of laxatives, and severity of abdominal bloating and distention. Impact of constipation on 15 QOL domains. | Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion |
| Change in Hospital Anxiety and Depression (HAD) score | The Hospital Anxiety and Depression (HAD) is a self-reported 14 item questionnaire asking participants to reflect on their mood in the past week. . Each item is rated on a 4-point scale, for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress. | Baseline, through study completion, an average of 16 weeks |
| Change in forced vital capacity | Forced vital capacity (FVC) is the the total volume of air exhaled with maximal effort, and is measured using a spirometer (reported in liters). | Baseline, through study completion, an average of 16 weeks |
| Change in forced expiratory volume | Forced expiratory volume (FEV) is the total volume of air exhaled with maximal effort, and is measured using a spirometer (reported in liters). | Baseline, through study completion, an average of 16 weeks |
| Change in forced expiratory time | Forced expiratory time (FET) is the time taken to exhale the greatest volume of air from the lungs as possible and is measured using a spirometer (reported in seconds). | Baseline, through study completion, an average of 16 weeks |
| Change in peak inspiratory flows | Peak inspiratory flow (PIF) is the maximum volume and rate of air that can be forcefully inhaled out of the lungs, and is measured using a spirometer (reported in liters per second (L/sec)). | Baseline, through study completion, an average of 16 weeks |
| Change in peak expiratory flows | Peak expiratory flow (PEF) is the maximum volume and rate of air that can be forcefully exhaled out of the lungs and is measured using a spirometer (reported in in liters per second (L/sec)). | Baseline, through study completion, an average of 16 weeks |
| Change in forced expiratory volume/forced vital capacity ratio | The total volume of air exhaled with maximal effort / The volume of air exhaled with maximum effort in the first second (reported as percentage). | Baseline, through study completion, an average of 16 weeks |
| Change in forced expiratory flow at 25-75% of forced vital capacity | The average flow from the point at which 25% of the forced vital capacity has been exhaled to the point at which 75% of the forced vital capacity has been exhaled. A reduced forced expiratory flow 25-75% is a marker of small airway obstruction. | Baseline, through study completion, an average of 16 weeks |
| Change in forced expiratory flow at 50% of forced vital capacity | The flow rate at the point at which 50% point of the forced vital capacity has been exhaled, and is a marker of small airway obstruction. | Baseline, through study completion, an average of 16 weeks |
| Change in forced inspiratory vital capacity | Forced inspiratory vital capacity is the maximum volume of air that can be inhaled after a full expiration (reported in liters). | Baseline, through study completion, an average of 16 weeks |
| Change in peak inspiratory pressure | Peak inspiratory pressure is the peak pressure during forceful inspiration against an occluded airway (Mueller maneuver), reported in liters per minute (L/min) | Baseline, through study completion, an average of 16 weeks |
| Change in peak expiratory pressure | Peak expiratory pressure is the peak pressure during forceful expiration against an occluded airway (Valsalva maneuver), reported in liters per minute (L/min) | Baseline, through study completion, an average of 16 weeks |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |