Cystic FibrosisSTIMUCONCT00391703
Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis
A study testing Electrostimulation programme: using a cycloergometer and Usual sport activity in people with Cystic Fibrosis and Mucoviscidosis, run by University Hospital, Grenoble at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Mucoviscidosis
- What is being tested?
- Electrostimulation programme: using a cycloergometer and Usual sport activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2006to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant women
- Contraindication to application of magnetic field
- Pacemaker
- History of neurosurgical intervention
- Presence of metallic particles near the stimulation site.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Pneumology Department of Grenoble University Hospital
Grenoble, Isere, 38043
Pneumology Department of Lyon University Hospital
Lyon, Rhone, 69000
About this study
Official title: Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Mucoviscidosis
- Being tested
- Electrostimulation programme: using a cycloergometer, Usual sport activity
- Keywords
- Cystic fibrosis, mucoviscidosis, electrostimulation, retraining
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrostimulation programme: using a cycloergometerBehavioural
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
Usual sport activityBehavioural
Usual sport activity performed prior to an endurance retraining program using a cycloergometer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer Receives: Behavioral: Electrostimulation programme: using a cycloergometer |
| 2 | Active comparator | Usual sport activity, performed prior to an endurance retraining program using a cycloergometer Receives: Behavioral: Usual sport activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The six-minute walking distance
Measured: 0, 1, 2 months
Secondary outcomes (9)
Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation
Measured: 1 month
Inspiratory reserve volume (IRV), gasometry, dyspnea score
Measured: 0, 1, 2 months
Measurement of voluntary maximum force and non cooperative force of the quadriceps
Measured: 0, 1, 2 months
Area of quadriceps cross section measured with a scanner
Measured: 1, 2 months
Quadriceps muscle mass
Measured: 0, 1, 2 months
Quality of life: CFQ14, BDI-TDI questionnaires
Measured: 0, 1, 2 months
Compliance with ergocycle rehabilitation
Measured: 1 month
HOMA and QUICKI tests
Measured: 0, 1, 2 months
Spirometry
Measured: 0, 1, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionNov 2009
- Study completionSep 2010
Why it stopped: enrolment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose
- Investigators
- Claire Cracowski, Dr, Study director, Pneumology Department of Grenoble University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391703
- Sponsor's protocol ID
- DCIC05/31
- Acronym
- STIMUCO
- Status last verified
- Nov 2010
- First submitted
- 23 Oct 2006
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Pin I, Grenet D, Scheid P, Domblides P, Stern M, Hubert D. [Specific aspects and care of lung involvement in adults with cystic fibrosis]. Rev Mal Respir. 2000 Aug;17(3 Pt 2):758-78. French.
PubMed 11076386de Meer K, Gulmans VA, van Der Laag J. Peripheral muscle weakness and exercise capacity in children with cystic fibrosis. Am J Respir Crit Care Med. 1999 Mar;159(3):748-54. doi: 10.1164/ajrccm.159.3.9802112.
PubMed 10051246Selvadurai HC, Allen J, Sachinwalla T, Macauley J, Blimkie CJ, Van Asperen PP. Muscle function and resting energy expenditure in female athletes with cystic fibrosis. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1476-80. doi: 10.1164/rccm.200303-363OC. Epub 2003 Sep 18.
PubMed 14500260Lands LC, Heigenhauser GJ, Jones NL. Respiratory and peripheral muscle function in cystic fibrosis. Am Rev Respir Dis. 1993 Apr;147(4):865-9. doi: 10.1164/ajrccm/147.4.865.
PubMed 8466121Elkin SL, Williams L, Moore M, Hodson ME, Rutherford OM. Relationship of skeletal muscle mass, muscle strength and bone mineral density in adults with cystic fibrosis. Clin Sci (Lond). 2000 Oct;99(4):309-14.
PubMed 10995596de Meer K, Jeneson JA, Gulmans VA, van der Laag J, Berger R. Efficiency of oxidative work performance of skeletal muscle in patients with cystic fibrosis. Thorax. 1995 Sep;50(9):980-3. doi: 10.1136/thx.50.9.980.
PubMed 8539680Moser C, Tirakitsoontorn P, Nussbaum E, Newcomb R, Cooper DM. Muscle size and cardiorespiratory response to exercise in cystic fibrosis. Am J Respir Crit Care Med. 2000 Nov;162(5):1823-7. doi: 10.1164/ajrccm.162.5.2003057.
PubMed 11069820Vivodtzev I, Decorte N, Wuyam B, Gonnet N, Durieu I, Levy P, Cracowski JL, Cracowski C. Benefits of neuromuscular electrical stimulation prior to endurance training in patients with cystic fibrosis and severe pulmonary dysfunction. Chest. 2013 Feb 1;143(2):485-493. doi: 10.1378/chest.12-0584.
PubMed 22911373
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction
- ClinicalTrials.gov ID
- NCT00391703
- Acronym / sponsor ID
- STIMUCO / DCIC05/31
- Conditions
- Cystic Fibrosis, Mucoviscidosis
- Keywords
- Cystic fibrosis, mucoviscidosis, electrostimulation, retraining
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrolment difficulties
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose
- Study start
- Oct 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Electrostimulation programme: using a cycloergometerQuadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer |
| 2 | Active comparator | Behavioral: Usual sport activityUsual sport activity, performed prior to an endurance retraining program using a cycloergometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnant women
- Contraindication to application of magnetic field
- Pacemaker
- History of neurosurgical intervention
- Presence of metallic particles near the stimulation site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrostimulation programme: using a cycloergometerQuadriceps 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 | Behavioural | 1 |
| Usual sport activityUsual sport activity performed prior to an endurance retraining program using a cycloergometer | Behavioural | 2 |
Primary outcome
The six-minute walking distance
Time frame: 0, 1, 2 months
9 secondary outcomes
Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation
Time frame: 1 month
Inspiratory reserve volume (IRV), gasometry, dyspnea score
Time frame: 0, 1, 2 months
Measurement of voluntary maximum force and non cooperative force of the quadriceps
Time frame: 0, 1, 2 months
Area of quadriceps cross section measured with a scanner
Time frame: 1, 2 months
Quadriceps muscle mass
Time frame: 0, 1, 2 months
Quality of life: CFQ14, BDI-TDI questionnaires
Time frame: 0, 1, 2 months
Compliance with ergocycle rehabilitation
Time frame: 1 month
HOMA and QUICKI tests
Time frame: 0, 1, 2 months
Spirometry
Time frame: 0, 1, 2 months
Results and safety
The study was stopped early (reason given: enrolment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
- Background: PubMed 11076386Pin I, Grenet D, Scheid P, Domblides P, Stern M, Hubert D. [Specific aspects and care of lung involvement in adults with cystic fibrosis]. Rev Mal Respir. 2000 Aug;17(3 Pt 2):758-78. French.
- Background: PubMed 10051246de Meer K, Gulmans VA, van Der Laag J. Peripheral muscle weakness and exercise capacity in children with cystic fibrosis. Am J Respir Crit Care Med. 1999 Mar;159(3):748-54. doi: 10.1164/ajrccm.159.3.9802112.
- Background: PubMed 14500260Selvadurai HC, Allen J, Sachinwalla T, Macauley J, Blimkie CJ, Van Asperen PP. Muscle function and resting energy expenditure in female athletes with cystic fibrosis. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1476-80. doi: 10.1164/rccm.200303-363OC. Epub 2003 Sep 18.
- Background: PubMed 8466121Lands LC, Heigenhauser GJ, Jones NL. Respiratory and peripheral muscle function in cystic fibrosis. Am Rev Respir Dis. 1993 Apr;147(4):865-9. doi: 10.1164/ajrccm/147.4.865.
- Background: PubMed 10995596Elkin SL, Williams L, Moore M, Hodson ME, Rutherford OM. Relationship of skeletal muscle mass, muscle strength and bone mineral density in adults with cystic fibrosis. Clin Sci (Lond). 2000 Oct;99(4):309-14.
- Background: PubMed 8539680de Meer K, Jeneson JA, Gulmans VA, van der Laag J, Berger R. Efficiency of oxidative work performance of skeletal muscle in patients with cystic fibrosis. Thorax. 1995 Sep;50(9):980-3. doi: 10.1136/thx.50.9.980.
- Background: PubMed 11069820Moser C, Tirakitsoontorn P, Nussbaum E, Newcomb R, Cooper DM. Muscle size and cardiorespiratory response to exercise in cystic fibrosis. Am J Respir Crit Care Med. 2000 Nov;162(5):1823-7. doi: 10.1164/ajrccm.162.5.2003057.
- Derived from this study: PubMed 22911373Vivodtzev I, Decorte N, Wuyam B, Gonnet N, Durieu I, Levy P, Cracowski JL, Cracowski C. Benefits of neuromuscular electrical stimulation prior to endurance training in patients with cystic fibrosis and severe pulmonary dysfunction. Chest. 2013 Feb 1;143(2):485-493. doi: 10.1378/chest.12-0584.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Cracowski, Dr study director
Pneumology Department of Grenoble University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrostimulation programme: using a cycloergometer and Usual sport activity in people with Cystic Fibrosis and Mucoviscidosis, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: enrolment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The six-minute walking distance (time frame: 0, 1, 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391703, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2010.