Skip to content

Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis

Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00391703
Acronym
STIMUCO
Enrollment
40
Registered
2006-10-24
Start date
2006-10-31
Completion date
2010-09-30
Last updated
2010-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Mucoviscidosis

Keywords

Cystic fibrosis, mucoviscidosis, electrostimulation, retraining

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.

Interventions

BEHAVIORALElectrostimulation programme: using a cycloergometer

Quadriceps electrostimulation programme performed prior to an endurance retraining program using a cycloergometer, for 6 weeks, 60 to 90 minutes by session, 5 to 6 sessions per week

BEHAVIORALUsual sport activity

Usual sport activity performed prior to an endurance retraining program using a cycloergometer

Sponsors

Vaincre la Mucoviscidose
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Pregnant women * Contraindication to application of magnetic field * Pacemaker * History of neurosurgical intervention * Presence of metallic particles near the stimulation site.

Design outcomes

Primary

MeasureTime frame
The six-minute walking distance0, 1, 2 months

Secondary

MeasureTime frame
Inspiratory reserve volume (IRV), gasometry, dyspnea score0, 1, 2 months
Measurement of voluntary maximum force and non cooperative force of the quadriceps0, 1, 2 months
Area of quadriceps cross section measured with a scanner1, 2 months
Quadriceps muscle mass0, 1, 2 months
Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation1 month
Compliance with ergocycle rehabilitation1 month
HOMA and QUICKI tests0, 1, 2 months
Spirometry0, 1, 2 months
Quality of life: CFQ14, BDI-TDI questionnaires0, 1, 2 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026