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The main objective of this clinical pilot study is to evaluate the feasibility and impact of a home-based exercise program on clinical and patient-centered outcomes in adult with cystic fibrosis (CF) and inform the design of a larger clinical trial.
This pilot and feasibility study is a randomized controlled trial comparing exercise intervention with a usual care group. Participants will be randomized based on a randomization table developed by a biostatistician who is not involved in the study. The exercise intervention group will be delivered with a telehealth platform using internet (Zoom HIPAA-Compliant video), an app, phone, and email/text support. Participants will be randomly allocated to either an exercise coaching program or a usual care arm. The exercise intervention arm will follow guidelines established by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and complement best clinical practices established by the American Thoracic Society/European Respiratory Society (ATS/ERS). The usual care arm will be provided a handout on resources for engaging in physical activity.
Aim 1. Examine the feasibility of a home-based Tele-rehab intervention. Indicators of feasibility will include recruitment and adherence. Hypothesis 1: Based on previous trials, the investigators predict that >50% of eligible participants will consent to the study. Hypothesis 2: Again, based on previous trials, >70% of participants in the intervention arm will adhere to >70% of their weekly prescribed exercise. Also, the investigators will assess reasons for; 1) eligible patients who don't enroll, 2) participants' non-adherence, and 3) non-completers.
Aim 2. Evaluate the impact of a home-based exercise program in adults with CF for improving clinical and patient-centered outcomes. Hypothesis 1: There will be a greater improvement in exercise capacity (measured by a modified shuttle test), a novel measure of lung function 129Xenon MRI (129Xe MRI), forced expiratory volume in 1 second (FEV1), and quality of life with participants in the intervention arm when compared to usual care. Hypothesis 2: Changes in exercise capacity and 129Xe MRI will be associated with exercise adherence, as noted in Aim 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenon MRI only, without exerercise intervention | Other | Participants will receive usual standard of care and undergo a xenon MRI. |
|
| Xenon MRI with exercise coaching | Active Comparator | Participants will receive weekly coaching intervention and undergo a xenon MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon MRI | Diagnostic Test | Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result | change in number of modified shuttles completed between baseline/enrollment and study completion at 3 months | 3 months |
| Ventilation Defect Percentage (VDP) as Detected by 129Xenon MRI | Hyperpolarized 129Xe ventilation MRI will be performed to assess VDP at baseline (within 2 weeks of initiation of study) and after completion of the intervention/usual care-control period | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1 Second | lung function will be assessed at baseline/enrollment and study completion at 3 months | 3 months |
| Quality of Life Assessment. | Cystic Fibrosis questionnaire-revised (CFQR) will be assessed at baseline/enrollment and study completion at 3 months. Scale 0-100 (high score indicates better quality of life) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Burnett, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
Pilot participant data available upon request by other researchers
at completion of study analysis. no planned end date
upon request to primary investigator
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| ID | Title | Description |
|---|---|---|
| FG000 | Xenon MRI Only, Without Exerercise Intervention | Participants will receive usual standard of care and undergo a xenon MRI. Xenon MRI: Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention. |
| FG001 | Xenon MRI With Exercise Coaching | Participants will receive weekly coaching intervention and undergo a xenon MRI Xenon MRI: Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xenon MRI Only, Without Exerercise Intervention | Participants will receive usual standard of care and undergo a xenon MRI. Xenon MRI: Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result | change in number of modified shuttles completed between baseline/enrollment and study completion at 3 months | Posted | Mean | Standard Deviation | change shuttles (1 shuttle is 10 meters) | 3 months |
|
study duration, 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xenon MRI Only, Without Exerercise Intervention | Participants will receive usual standard of care and undergo a xenon MRI. Xenon MRI: Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Mermis | University of Kansas Medical Center | 913-588-6045 | jmermis@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2024 | Nov 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2024 | Nov 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
|
| 3 months |
| Exercise Time | assess weekly adherence to prescribed exercise time completed | 3 months |
| BG001 | Xenon MRI With Exercise Coaching | Participants will receive weekly coaching intervention and undergo a xenon MRI Xenon MRI: Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Xenon MRI With Exercise Coaching | Participants will receive weekly coaching intervention and undergo a xenon MRI Xenon MRI: Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention. |
|
|
| Primary | Ventilation Defect Percentage (VDP) as Detected by 129Xenon MRI | Hyperpolarized 129Xe ventilation MRI will be performed to assess VDP at baseline (within 2 weeks of initiation of study) and after completion of the intervention/usual care-control period | Posted | Mean | Standard Deviation | percentage of lung with low ventilation | 3 months |
|
|
|
| Secondary | Forced Expiratory Volume in 1 Second | lung function will be assessed at baseline/enrollment and study completion at 3 months | Posted | Mean | Standard Deviation | change pre/post FEV1 percent predicted | 3 months |
|
|
|
| Secondary | Quality of Life Assessment. | Cystic Fibrosis questionnaire-revised (CFQR) will be assessed at baseline/enrollment and study completion at 3 months. Scale 0-100 (high score indicates better quality of life) | Posted | Mean | Standard Deviation | change pre/post CFQR score | 3 months |
|
|
|
| Secondary | Exercise Time | assess weekly adherence to prescribed exercise time completed | Participants in the Xenon MRI only without exercise intervention group did not record exercise minutes as they did not have exercise coaching intervention | Posted | Mean | Full Range | Minutes | 3 months |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Xenon MRI With Exercise Coaching | Participants will receive weekly coaching intervention and undergo a xenon MRI Xenon MRI: Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |