Safety and Feasibility of High-intensity Interval Training Program in CF Patients

Cystic Fibrosis Clinical Trial

— ITHI  

Official title:

Assessment of the Safety and Feasibility of a High-intensity Interval Training Program in Adult CF Patients: a Randomized Bicentric Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888767
• Other study ID #: ILDYS-ISC2-2020-002
• Secondary ID: ID-RCB
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 13, 2023

Study information

• Verified date: September 2023
• Source: Fondation Ildys
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 ; patients treated with modulating CFTR canal therapy ; diabetic patients on insulin ; undernourished patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 13, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
France	CF Center of Giens - Hospices Civils de Lyon Hôpital Renée Sabran	Giens	Hyères
France	CF Center - Fondation Ildys Site de Perharidy	Roscoff	Finistère

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ildys	Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Secondary	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)
Secondary	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	Change from baseline (Day 2) at 3 weeks (Day 18)
Secondary	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)
Secondary	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)
Secondary	Continuous blood sugar levels	Evaluation of the glucose levels (average, minimum, maximum)	Continuous measurement over the entire stay (Day 1 to Day 18)
Secondary	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
Secondary	Impedance	Bioelectrical impedance analysis of body composition	Change from baseline (Day 2) at 3 weeks (Day 18)
Secondary	Spirometry	Respiratory capacity assessment : forced expiratory volume in 1 second (FEV1)	Change from baseline (Day 2) at 3 weeks (Day 18)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)