Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2021-A00512-39 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lille Catholic University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
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
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Patients benefiting from the usual re-training sessions | |
| ITHI Group | Experimental | Patients benefiting from ITHI re-training sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interval Training Hight Intensity Program | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasability evaluation | Proportion of sessions carried out according to the planned program (and, in parallel, number and reasons for stopping sessions or the program) | Continuous measurement over the entire stay (Day 1 to Day 18) |
| Tolerance evaluation | Scores on the Borg scale (physical activity dyspnea and muscle fatigue) : 0 to 10 - Higher score = worse outcome | Change from baseline (Day 2) at 3 weeks (Day 18) |
| Measure | Description | Time Frame |
|---|---|---|
| Cystic Fibrosis Questionnaire Revised (CFQR) | Scores on CFQR (assessment of quality of life) : 0 to 100 - Higher score = better outcome | Change from baseline (Day 2) at 3 weeks (Day 18) |
| Hospital Anxiety and Depression scale (HAD) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sophie Ramel, MD | Fondation Ildys | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CF Center - Fondation Ildys Site de Perharidy | Roscoff | Finistère | 29684 | France | ||
| CF Center of Giens - Hospices Civils de Lyon Hôpital Renée Sabran |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Scores on HAD : 2 scores (1 for anxiety and 1 for depression) - 0 to 21 - Higher score = worse outcome
| Change from baseline (Day 2) at 3 weeks (Day 18) |
| Starfish | Scores on the "starfish": assesment of the feelings about physical activity with an educational diagram - 12 "branches" = 12 sub-scores - 0 to 12 - Higher score = better outcome | Change from baseline (Day 2) at 3 weeks (Day 18) |
| Anthropometry | Weight (Kg) and height (cm) will be combined to report BMI in kg/m2 | Change from baseline (Day 1) at 3 weeks (Day 18) |
| Continuous blood sugar levels | Evaluation of the glucose levels (average, minimum, maximum) | Continuous measurement over the entire stay (Day 1 to Day 18) |
| Ponctual blood sugar levels | Blood glucose assessment during re-training sessions (at the start; during; at the end; after recovery) | Measurement at each sessions from Day 2 to Day 18 |
| Impedance | Bioelectrical impedance analysis of body composition | Change from baseline (Day 2) at 3 weeks (Day 18) |
| Spirometry | Respiratory capacity assessment : forced expiratory volume in 1 second (FEV1) | Change from baseline (Day 2) at 3 weeks (Day 18) |
| Maximal Voluntary force : Strength | Best measurement, in Newton, of thigh quadriceps strength after 6 evaluations (3 with the left thigh and 3 with the right thigh) | Change from baseline (Day 2) at 3 weeks (Day 18) |
| Maximal Voluntary force : endurance | Best measurement, in second, of thigh quadriceps strength after 2 evaluations (13 with the left thigh and 1 with the right thigh) | Change from baseline (Day 2) at 3 weeks (Day 18) |
| 6MWT | Measurement of the distance traveled during the six minutes walk test (6MWT) and of several related parameters (dyspnea, oxygen saturation, heart rate - at the start, at the finish, after rest) | Change from baseline (Day 12) at 3 weeks (Day 18) |
| Multidimensional dyspnea profile scale (MDP) | Scores on the MDP : assessment of discomfort (0 to 10), sensory component (0 to 50) and affective component (0 to 50) of breathlessness -> 3 sub-scores - Higher score = worse outcome | Change from baseline (Day 2) at 3 weeks (Day 18) |
| Physical Activity Enjoyment Scale (PACES) | Score on the PACES : assessment of global satisfaction felt during re-training sessions - 10 to 70 - Higher score = better outcome | Measurement at the end of the stay (Day 18) |
| Giens |
| Hyères |
| 83400 |
| France |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001519 | Behavior |