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

NCT ID: NCT04888767

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-09-13

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Patients benefiting from the usual re-training sessions

Group Type: NO_INTERVENTION

No interventions assigned to this group

ITHI Group

Patients benefiting from ITHI re-training sessions

Group Type: EXPERIMENTAL

Interval Training Hight Intensity Program

Intervention Type: OTHER

• 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lille Catholic University

OTHER

Sponsor Role: collaborator

Fondation Ildys

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Ramel, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ildys

Locations

CF Center - Fondation Ildys Site de Perharidy

Roscoff, Finistère, France

CF Center of Giens - Hospices Civils de Lyon Hôpital Renée Sabran

Giens, Hyères, France

Countries

France

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

ILDYS-ISC2-2020-002

Identifier Type: -

Identifier Source: org_study_id