Clinical trial NCT04888767: Safety and Feasibility of High-intensity Interval Training Program in CF Patients
Official title: Assessment of the Safety and Feasibility of a High-intensity Interval Training Program in Adult CF Patients: a Randomized Bicentric Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Respiratory rehabilitation program
Physical activity
High intensity interval training
Quality of life
Lead sponsor: Fondation Ildys
Sponsor class: OTHER
Collaborators: name: Lille Catholic University
First posted: 2021-05-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Bicentric; prospective; opened ; randomized; controlled study
* Distribution of patients in groups according to a ratio (1:1)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* men and women aged over 18 years of age on the date of informed consent
* diagnosed CF patients
* not transplanted and not on the transplant waiting list
* able to participate in the proposed training programs (especially without cardiac contraindication)
* able to understand and respect the protocol and its requirement
* who signed the consent prior to any other procedure protocol

Exclusion Criteria:

* major patients under guardianship / curatorship / legal protection
* pregnant patients
* dialysis patients
* patients with a severe exacerbation at the time of inclusion
* patients for whom a new modulating treatment (eg.: Kaftrio®, Kalydeco®, Symkevi®, etc.) has been implemented in the 4 weeks preceding inclusion
* patients with pulmonary arterial hypertension (≥ 25 mmHg)
* patients unable to complete the entire program

Primary outcomes:
measure: Feasability evaluation
timeFrame: Continuous measurement over the entire stay (Day 1 to Day 18)
measure: Tolerance evaluation
timeFrame: Change from baseline (Day 2) at 3 weeks (Day 18)
Secondary outcomes:
measure: Cystic Fibrosis Questionnaire Revised (CFQR)
timeFrame: Change from baseline (Day 2) at 3 weeks (Day 18)
measure: Hospital Anxiety and Depression scale (HAD)
timeFrame: Change from baseline (Day 2) at 3 weeks (Day 18)
measure: Starfish
timeFrame: Change from baseline (Day 2) at 3 weeks (Day 18)
measure: Anthropometry
timeFrame: Change from baseline (Day 1) at 3 weeks (Day 18)
measure: Continuous blood sugar levels
timeFrame: Continuous measurement over the entire stay (Day 1 to Day 18)
measure: Ponctual blood sugar levels
timeFrame: Measurement at each sessions from Day 2 to Day 18
measure: Impedance
timeFrame: Change from baseline (Day 2) at 3 weeks (Day 18)
measure: Spirometry
timeFrame: Change from baseline (Day 2) at 3 weeks (Day 18)
measure: Maximal Voluntary force : Strength
timeFrame: Change from baseline (Day 2) at 3 weeks (Day 18)
measure: Maximal Voluntary force : endurance
timeFrame: Change from baseline (Day 2) at 3 weeks (Day 18)
measure: 6MWT
timeFrame: Change from baseline (Day 12) at 3 weeks (Day 18)
measure: Multidimensional dyspnea profile scale (MDP)
timeFrame: Change from baseline (Day 2) at 3 weeks (Day 18)
measure: Physical Activity Enjoyment Scale (PACES)
timeFrame: Measurement at the end of the stay (Day 18)
Other outcomes:
Locations:
city: Roscoff
country: France
facility: CF Center - Fondation Ildys Site de Perharidy
state: Finistère
city: Giens
country: France
facility: CF Center of Giens - Hospices Civils de Lyon Hôpital Renée Sabran
state: Hyères
Study officials:
affiliation: Fondation Ildys
name: Sophie Ramel, MD
role: PRINCIPAL_INVESTIGATOR
References: