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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Interval Training Hight Intensity Program

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Finistère
    • Roscoff, Finistère, France, 29684
      • CF Center - Fondation Ildys Site de Perharidy
  • Hyères
    • Giens, Hyères, France, 83400
      • CF Center of Giens - Hospices Civils de Lyon Hôpital Renée Sabran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients benefiting from the usual re-training sessions
Experimental: ITHI Group; 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 physiotherapistControl group: 5 times / week; continuous work 20 to 30 min; around the 1st aerobic ventilation thresholdIntervention 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Fondation Ildys
• Collaborators: Lille Catholic University
• Investigators: Principal Investigator: Sophie Ramel, MD, Fondation Ildys

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Physical activity; Cystic fibrosis; High intensity interval training; Respiratory rehabilitation program
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: ILDYS-ISC2-2020-002; ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No