Trial Outcomes & Findings for Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis (NCT NCT05239611)
NCT ID: NCT05239611
Last Updated: 2025-06-12
Results Overview
change in number of modified shuttles completed between baseline/enrollment and study completion at 3 months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
3 months
Results posted on
2025-06-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Xenon MRI Only, Without Exerercise Intervention
n=9 Participants
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.
|
Xenon MRI With Exercise Coaching
n=12 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
28 years
n=9 Participants
|
32 years
n=12 Participants
|
30.6 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
7 Participants
n=12 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
5 Participants
n=12 Participants
|
13 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
12 participants
n=12 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 monthschange in number of modified shuttles completed between baseline/enrollment and study completion at 3 months
Outcome measures
| Measure |
Xenon MRI Only, Without Exerercise Intervention
n=9 Participants
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.
|
Xenon MRI With Exercise Coaching
n=12 Participants
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.
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|---|---|---|
|
Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result
|
-6.67 change shuttles (1 shuttle is 10 meters)
Standard Deviation 9.33
|
-7.63 change shuttles (1 shuttle is 10 meters)
Standard Deviation 9.84
|
PRIMARY outcome
Timeframe: 3 monthsHyperpolarized 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
Outcome measures
| Measure |
Xenon MRI Only, Without Exerercise Intervention
n=9 Participants
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.
|
Xenon MRI With Exercise Coaching
n=12 Participants
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.
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|---|---|---|
|
Ventilation Defect Percentage (VDP) as Detected by 129Xenon MRI
|
20.7 percentage of lung with low ventilation
Standard Deviation 9.0
|
24.2 percentage of lung with low ventilation
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: 3 monthslung function will be assessed at baseline/enrollment and study completion at 3 months
Outcome measures
| Measure |
Xenon MRI Only, Without Exerercise Intervention
n=6 Participants
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.
|
Xenon MRI With Exercise Coaching
n=8 Participants
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.
|
|---|---|---|
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Forced Expiratory Volume in 1 Second
|
1.2 change pre/post FEV1 percent predicted
Standard Deviation 4.66
|
-0.38 change pre/post FEV1 percent predicted
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: 3 monthsCystic 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)
Outcome measures
| Measure |
Xenon MRI Only, Without Exerercise Intervention
n=6 Participants
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.
|
Xenon MRI With Exercise Coaching
n=8 Participants
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.
|
|---|---|---|
|
Quality of Life Assessment.
|
-2.0 change pre/post CFQR score
Standard Deviation 10.82
|
-4.91 change pre/post CFQR score
Standard Deviation 7.06
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants in the Xenon MRI only without exercise intervention group did not record exercise minutes as they did not have exercise coaching intervention
assess weekly adherence to prescribed exercise time completed
Outcome measures
| Measure |
Xenon MRI Only, Without Exerercise Intervention
n=12 Participants
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.
|
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.
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|---|---|---|
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Exercise Time
|
1290 Minutes
Interval 285.0 to 2500.0
|
—
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Adverse Events
Xenon MRI Only, Without Exerercise Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Xenon MRI With Exercise Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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