An interventional study of Interval Training Hight Intensity Program in Cystic Fibrosis, sponsored by Fondation Ildys. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Fondation Ildys · Not applicable, Interventional, and Treatment
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
Rehabilitation stay in hospitalization with 18 days of training, on an ergometer, supervised by an APA teacher or a physiotherapist
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 62 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Fondation Ildys is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients benefiting from the usual re-training sessions
Patients benefiting from ITHI re-training sessions
Other: Interval Training Hight Intensity Program
* Rehabilitation stay in hospitalization with 18 days of training sessions * Training on an ergometer * Sessions supervised by an Adapted Physical Activities (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
Feasability evaluation
Proportion of sessions carried out according to the planned program (and, in parallel, number and reasons for stopping sessions or the program)
Time frame: 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
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Cystic Fibrosis Questionnaire Revised (CFQR)
Scores on CFQR (assessment of quality of life) : 0 to 100 - Higher score = better outcome
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Hospital Anxiety and Depression scale (HAD)
Scores on HAD : 2 scores (1 for anxiety and 1 for depression) - 0 to 21 - Higher score = worse outcome
Time frame: 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
Time frame: 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
Time frame: Change from baseline (Day 1) at 3 weeks (Day 18)
Continuous blood sugar levels
Evaluation of the glucose levels (average, minimum, maximum)
Time frame: 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)
Time frame: Measurement at each sessions from Day 2 to Day 18
Impedance
Bioelectrical impedance analysis of body composition
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Spirometry
Respiratory capacity assessment : forced expiratory volume in 1 second (FEV1)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Measurement at the end of the stay (Day 18)
Plan to share: No
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