Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis
- Conditions
- MucoviscidosisCystic Fibrosis
- Interventions
- Behavioral: Usual sport activity
- Registration Number
- NCT00391703
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
This is an add-on, randomized, open label, clinical trial that evaluates the use of quadriceps electrostimulation as an additional retraining procedure in patients suffering from cystic fibrosis.
- Detailed Description
Cystic fibrosis is an autosomal recessive genetic disease due to a mutation of the CFTR protein gene. The CFTR protein transports chloride ions (Cl-) across cell membranes in the lungs, pancreas, digestive tract, reproductive tract, and skin.
CFTR mutation mainly leads to a dysfunction of the pulmonary system and pancreas exocrine function.
Several studies showed that cystic fibrosis commonly induces a reduction of effort tolerance, peripheral muscular strength and work capacity.
Patients suffering from cystic fibrosis with a high endurance capacity have a lower risk of poor prognosis. Those with a severe dyspnea have a higher benefit with a force training or a combined force and endurance training than with endurance training alone.
We propose to study the effect of a quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer, in patients with cystic fibrosis associated with severe pulmonary dysfunction, to enhance their muscular performance and increase their adherence to the cycloergometer retraining program.
This is a randomized trial with two groups:
Group A: experimental group, twenty patients. Six weeks with electrostimulation program followed by six weeks under a cycloergometer program.
Group B: control group, twenty patients. Six weeks with their usual physical activity followed by six weeks with a cycloergometer program.
The Randomization is stratified on expiratory volume per second. The size of randomization blocks is random because of the open design.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
- Age >= 18 years
- Patient suffering from cystic fibrosis
- Patient has at least three measures of maximum expiratory volume per second <= 45% of the theory among the 6 last measures performed
- Affiliation to French social security
- Capacity to consent
- Pregnant women
- Contraindication to application of magnetic field
- Pacemaker
- History of neurosurgical intervention
- Presence of metallic particles near the stimulation site.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Usual sport activity Usual sport activity, performed prior to an endurance retraining program using a cycloergometer
- Primary Outcome Measures
Name Time Method The six-minute walking distance 0, 1, 2 months
- Secondary Outcome Measures
Name Time Method Quality of life: CFQ14, BDI-TDI questionnaires 0, 1, 2 months HOMA and QUICKI tests 0, 1, 2 months Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation 1 month Quadriceps muscle mass 0, 1, 2 months Compliance with ergocycle rehabilitation 1 month Inspiratory reserve volume (IRV), gasometry, dyspnea score 0, 1, 2 months Measurement of voluntary maximum force and non cooperative force of the quadriceps 0, 1, 2 months Area of quadriceps cross section measured with a scanner 1, 2 months Spirometry 0, 1, 2 months
Trial Locations
- Locations (2)
Pneumology Department of Lyon University Hospital
🇫🇷Lyon, Rhone, France
Pneumology Department of Grenoble University Hospital
🇫🇷Grenoble, Isere, France