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

NCT04888767 | Completed

• 2 other identifiers: ILDYS-ISC2-2020-002ID-RCB
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Respiratory rehabilitation program; Physical activity; High intensity interval training; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Cystic Fibrosis Questionnaire Revised (CFQR)

  Change from baseline (Day 2) at 3 weeks (Day 18)

• Hospital Anxiety and Depression scale (HAD)

  Change from baseline (Day 2) at 3 weeks (Day 18)

• Starfish

  Change from baseline (Day 2) at 3 weeks (Day 18)

• Anthropometry

  Change from baseline (Day 1) at 3 weeks (Day 18)

• Continuous blood sugar levels

  Continuous measurement over the entire stay (Day 1 to Day 18)

Study Arms (2)

Control group

NO INTERVENTION

Patients benefiting from the usual re-training sessions

ITHI Group

EXPERIMENTAL

Patients benefiting from ITHI re-training sessions

Other: Interval Training Hight Intensity Program

Interventions

Interval Training Hight Intensity Program 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

ITHI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• major patients under guardianship / curatorship / legal protection
• pregnant patients
• dialysis patients
• patients with pulmonary arterial hypertension (≥ 25 mmHg)
• patients unable to complete the entire program

Sponsors & Collaborators

• Fondation Ildys: lead
• Lille Catholic University: collaborator

Study Sites (2)

CF Center - Fondation Ildys Site de Perharidy

Roscoff, Finistère, 29684, France

Location

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

Giens, Hyères, 83400, France

Location

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• Sophie Ramel, MD

  Fondation Ildys

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Bicentric; prospective; opened ; randomized; controlled study * Distribution of patients in groups according to a ratio (1:1)

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 17, 2021
• Study Start: September 1, 2021
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)