Cystic FibrosisITHINCT04888767
Safety and Feasibility of High-intensity Interval Training Program in CF Patients
A study testing Interval Training Hight Intensity Program in people with Cystic Fibrosis, run by Fondation Ildys at 2 sites in France.
Trial 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 … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Interval Training Hight Intensity Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2021to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CF Center of Giens - Hospices Civils de Lyon Hôpital Renée Sabran
Giens, Hyères, 83400
CF Center - Fondation Ildys Site de Perharidy
Roscoff, Finistère, 29684
About this study
Official title: Assessment of the Safety and Feasibility of a High-intensity Interval Training Program in Adult CF Patients: a Randomized Bicentric Pilot Study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Interval Training Hight Intensity Program
- Keywords
- Cystic fibrosis, Respiratory rehabilitation program, Physical activity, High intensity interval training, Quality of life
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval Training Hight Intensity ProgramOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients benefiting from the usual re-training sessions |
| ITHI Group | Experimental | Patients benefiting from ITHI re-training sessions Receives: Other: Interval Training Hight Intensity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability evaluation
Proportion of sessions carried out according to the planned program (and, in parallel, number and reasons for stopping sessions or the program)
Measured: 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
Measured: Change from baseline (Day 2) at 3 weeks (Day 18)
Secondary outcomes (13)
Cystic Fibrosis Questionnaire Revised (CFQR)
Scores on CFQR (assessment of quality of life) : 0 to 100 - Higher score = better outcome
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline (Day 1) at 3 weeks (Day 18)
Continuous blood sugar levels
Evaluation of the glucose levels (average, minimum, maximum)
Measured: 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)
Measured: Measurement at each sessions from Day 2 to Day 18
Impedance
Bioelectrical impedance analysis of body composition
Measured: Change from baseline (Day 2) at 3 weeks (Day 18)
Spirometry
Respiratory capacity assessment : forced expiratory volume in 1 second (FEV1)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Measurement at the end of the stay (Day 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Sep 2021
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Bicentric; prospective; opened ; randomized; controlled study * Distribution of patients in groups according to a ratio (1:1)
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ildys
- Sponsor type
- University, hospital or other
- Collaborators
- Lille Catholic University
- Responsible party
- Sponsor
- Investigators
- Sophie Ramel, MD, Principal investigator, Fondation Ildys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888767
- Sponsor's protocol ID
- ILDYS-ISC2-2020-002
- Other IDs
- ID-RCB
- Acronym
- ITHI
- Status last verified
- Sep 2023
- First submitted
- 6 May 2021
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Feasibility of a High-intensity Interval Training Program in Adult CF Patients: a Randomized Bicentric Pilot Study
- ClinicalTrials.gov ID
- NCT04888767
- Acronym / sponsor ID
- ITHI / ILDYS-ISC2-2020-002
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Respiratory rehabilitation program, Physical activity, High intensity interval training, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fondation IldysUniversity, hospital or other
- Collaborators
- Lille Catholic University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Bicentric; prospective; opened ; randomized; controlled study * Distribution of patients in groups according to a ratio (1:1)
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients benefiting from the usual re-training sessions |
| ITHI Group | Experimental | Other: Interval Training Hight Intensity ProgramPatients benefiting from ITHI re-training sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | ITHI Group |
Primary outcome
Feasability evaluation
Time frame: Continuous measurement over the entire stay (Day 1 to Day 18)
Proportion of sessions carried out according to the planned program (and, in parallel, number and reasons for stopping sessions or the program)
Tolerance evaluation
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Scores on the Borg scale (physical activity dyspnea and muscle fatigue) : 0 to 10 - Higher score = worse outcome
13 secondary outcomes
Cystic Fibrosis Questionnaire Revised (CFQR)
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Hospital Anxiety and Depression scale (HAD)
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Starfish
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Anthropometry
Time frame: Change from baseline (Day 1) at 3 weeks (Day 18)
Continuous blood sugar levels
Time frame: Continuous measurement over the entire stay (Day 1 to Day 18)
Ponctual blood sugar levels
Time frame: Measurement at each sessions from Day 2 to Day 18
Impedance
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Spirometry
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Maximal Voluntary force : Strength
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Maximal Voluntary force : endurance
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
6MWT
Time frame: Change from baseline (Day 12) at 3 weeks (Day 18)
Multidimensional dyspnea profile scale (MDP)
Time frame: Change from baseline (Day 2) at 3 weeks (Day 18)
Physical Activity Enjoyment Scale (PACES)
Time frame: Measurement at the end of the stay (Day 18)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Ramel, MD principal investigator
Fondation Ildys
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval Training Hight Intensity Program in people with Cystic Fibrosis, run by Fondation Ildys at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability evaluation (time frame: Continuous measurement over the entire stay (Day 1 to Day 18)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.