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| Name | Class |
|---|---|
| American Physical Therapy Association | OTHER |
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The primary aim of this study will be to determine if the addition of aerobic interval and inspiratory muscle training (IMT) targeted at improving cardiopulmonary-based measures will further improve patient satisfaction scores in individuals with chronic constipation (CC) who report plateau or limited improvements in CC after demonstrating a corrected defecation pattern using anorectal biofeedback training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Physical Therapy With No Study Intervention | Active Comparator | Participants will receive 6 weeks of standard physical therapy and have reported satisfaction and respond with a numerical value of ≤3 on a chronic constipation numeric scale. Participants will receive no additional study interventions. |
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| Standard of Care Physical Therapy With Study Intervention | Experimental | Participants who receive 6 weeks of standard physical therapy and have reported non satisfaction and respond with a numerical value of >3 on a chronic constipation numeric scale and have been cleared of pelvic floor muscle dyssynergia. Participants will receive an additional 8 weeks of study intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Physical Therapy Care | Other | Standard physical therapy care. Six to eight, one hour sessions over the course of 4-6 weeks. For individuals with chronic constipation that includes biofeedback therapy, breathing techniques on the toilet, manual therapy to the abdominal wall, and education on toileting posture and favorable lifestyle habits for gut health. |
| Measure | Description | Time Frame |
|---|---|---|
| Change In Patient Assessment of Constipation Symptoms (PAC-SYM) | The PAC-SYM questionnaire is a 12 item questionnaire that consists of three subscales: abdominal, rectal, and stool. Each item is scored 0-4 (0: Absent, 1: Mild, 2: Moderate, 3: Severe, 4: Very Severe). A total raw score can range from 0-48. The final score is the average of the summed score divided by the number of items, ranging from 0: Absent, 1: Mild, 2: Moderate, 3: Severe, 4: Very Severe. | Baseline, 6 weeks, 14 weeks, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change In Distance by the Incremental Shuttle Walk Test (ISWT) | The Incremental Shuttle Walk Test (ISWT) is an incremental externally paced walking test and is generally used as an index of cardiorespiratory fitness. The primary outcome is the distance covered calculated from the completed number of shuttles. The ISWT distance can be used to track changes in exercise capacity over time. | Week 6, week 14 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Cahalin | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Coral Gables | Florida | 33146 | United States |
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| Aerobic and Inspiratory Muscle Training | Other | The exercise-based 3 times per week for 8 weeks intervention will consist of aerobic interval training and inspiratory muscle training (IMT) for a total duration of 30 minutes. Aerobic-based intervals will be performed at a moderate intensity. Aerobic modes of exercise will include upper extremity ergometer, treadmill, bike, or elliptical. |
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| Change In estimated oxygen consumption (eVO2) by the Incremental Shuttle Walk Test (ISWT) | The Incremental Shuttle Walk Test (ISWT) is an incremental externally paced walking test and is generally used as an index of cardiorespiratory fitness. Peak estimated oxygen consumption (eVO2) can be estimated with greater accuracy than other field tests using a linear prediction equation incorporating ISWT distance. | Week 6, week 14 |
| Change In Heart Rate Recovery (HRR) | Heart rate recovery (HRR) will be measured as the difference of the peak heart rate at the end of the first exercise session and one minute post exercise. This will be recorded through the Polar Heart Rate chest monitor. | Week 6, week 14 |
| Change In Maximal Inspiratory Pressure (PImax) | PImax will be measured via the test of incremental respiratory endurance (TIRE) using the Pro2fit device and application. | Week 6, week 14 |
| Change In Rand Short Form Health Survey Questionnaire (SF-36) scores | The SF-36 is a widely recognized outcome measure used to measure health status in a variety of populations. The measure consists of eight domains and each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores measure more disability and higher scores measure less disability. Scores represent the percentage of the total possible score achieved. Items in the same domain are averaged together to create 8 scale scores. | Week 6, week 14 |
| 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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