Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT04888767
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of High-intensity Interval Training Program in CF Patients
Sponsor:
Fondation Ildys
Organization:
Study Overview
Official Title:
Assessment of the Safety and Feasibility of a High-intensity Interval Training Program in Adult CF Patients: a Randomized Bicentric Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITHI
Brief Summary:
This study compare an usual training program (in continuous endurance) with an ITHI program over a period of 3 weeks, in France. The aim is to evaluate the safety and feasibility of this type of program in CF adults, and also more specifically, in subgroups:
patients divided according to the severity of their FEV1 ; patients treated with modulating CFTR canal therapy ; diabetic patients on insulin ; undernourished patients.
patients divided according to the severity of their FEV1 ; patients treated with modulating CFTR canal therapy ; diabetic patients on insulin ; undernourished patients.
Detailed Description:
Objectives Studies have shown good tolerance of High Intensity Interval Training (ITHI) in healthy people or in COPD with similar results obtained with continuous training regimen, but with less shortness of breath and muscle fatigue, greater pleasure and a positive impact on glycemia. Research in CF is still scarce.
We propose to compare our usual training program (in continuous endurance) with an ITHI program over a period of 3 weeks, corresponding to the length of the rehabilitation stay in France. Our aim is to evaluate the safety and feasibility of this type of program in CF adults, and also more specifically, in subgroups:
* patients divided according to the severity of their FEV1
* patients treated with modulating CFTR canal therapy
* diabetic patients on insulin
* undernourished patients (BMI ≤ 18.5)
Methodology
* Bicentric (Roscoff-Giens); prospective; opened; randomized; controlled
* Rehabilitation stay in hospitalization with 18 days of training, on an ergometer, supervised by an APA teacher or a physiotherapist
* Control group: 5 times / week; continuous work 20 to 30 min; around the 1st aerobic ventilation threshold
* Intervention group: 2 times / week: maintenance sessions + 3 times / week: IHTI sessions - alternating 30s work / 30s rest repeated 6 times; at 60% of the maximum heart rate at the 1st session then increase as fast and large as possible
* Distribution of the 100 patients included in a 1: 1 ratio
* Examinations / Questionnaires in current practice: medical consultation; quality of life (CFQ-R); anxiety-depression (HAD); "Starfish" (Feelings linked to physical activity) ; blood sugar (Freestyle); impedance measurement; respiratory capacity measurement ; Voluntary Driving Force; walk test (TM6); dyspnea scale (Borg)
* Study-specific measures: MDP (Multidimensional Profile of Dyspnea) and PACES (Physical Activity Enjoyment Scale) scales
Expected results
Through this pilot study we are expecting to answer several questions:
* are the safety and tolerance of an ITHI program at least equal if not better than that of a "classic" training?
* what about the most severe patients?
* could patients on modulator have ITHI training (treatment likely to increase creatine kinase - muscle enzyme -)?
* are diabetic patients more at risk of hypoglycaemia during an ITHI compared to traditional training?
* could undernourished patients participate in ITHI regimen?
Perspective If ITHI appears to be safe and well tolerated, it could be integrated into "classic" rehabilitation programs and represent an interesting alternative, depending on the profile of each patient. The effectiveness of the ITHI program will also be discussed by evaluating several parameters, including 6mn walking distance test (6MWD). The emerging trends would allow some recommendations and more in-depth studies.
We propose to compare our usual training program (in continuous endurance) with an ITHI program over a period of 3 weeks, corresponding to the length of the rehabilitation stay in France. Our aim is to evaluate the safety and feasibility of this type of program in CF adults, and also more specifically, in subgroups:
* patients divided according to the severity of their FEV1
* patients treated with modulating CFTR canal therapy
* diabetic patients on insulin
* undernourished patients (BMI ≤ 18.5)
Methodology
* Bicentric (Roscoff-Giens); prospective; opened; randomized; controlled
* Rehabilitation stay in hospitalization with 18 days of training, on an ergometer, supervised by an APA teacher or a physiotherapist
* Control group: 5 times / week; continuous work 20 to 30 min; around the 1st aerobic ventilation threshold
* Intervention group: 2 times / week: maintenance sessions + 3 times / week: IHTI sessions - alternating 30s work / 30s rest repeated 6 times; at 60% of the maximum heart rate at the 1st session then increase as fast and large as possible
* Distribution of the 100 patients included in a 1: 1 ratio
* Examinations / Questionnaires in current practice: medical consultation; quality of life (CFQ-R); anxiety-depression (HAD); "Starfish" (Feelings linked to physical activity) ; blood sugar (Freestyle); impedance measurement; respiratory capacity measurement ; Voluntary Driving Force; walk test (TM6); dyspnea scale (Borg)
* Study-specific measures: MDP (Multidimensional Profile of Dyspnea) and PACES (Physical Activity Enjoyment Scale) scales
Expected results
Through this pilot study we are expecting to answer several questions:
* are the safety and tolerance of an ITHI program at least equal if not better than that of a "classic" training?
* what about the most severe patients?
* could patients on modulator have ITHI training (treatment likely to increase creatine kinase - muscle enzyme -)?
* are diabetic patients more at risk of hypoglycaemia during an ITHI compared to traditional training?
* could undernourished patients participate in ITHI regimen?
Perspective If ITHI appears to be safe and well tolerated, it could be integrated into "classic" rehabilitation programs and represent an interesting alternative, depending on the profile of each patient. The effectiveness of the ITHI program will also be discussed by evaluating several parameters, including 6mn walking distance test (6MWD). The emerging trends would allow some recommendations and more in-depth studies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID-RCB | OTHER | 2021-A00512-39 | View |