Cystic Fibrosis in ChildrenECOMIRINNCT04153669
Exercise With or Without Electrical Stimulation in Cystic Fibrosis (Part I): Effects on Physical Fitness
A study testing Exercise-NMES and Exercise-No NMES in people with Cystic Fibrosis in Children, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
This study aims to assess the effects of programmed exercise with or without electrical stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two interventions with a control group. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- Exercise-NMES and Exercise-No NMES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2019to 9 Mar 2020
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of CF
- Age: 6-18 years old
- Signature of informed consent of legal guardian and patient.
Who cannot join
- Being a smoker
- Having had an exacerbation in the last 3 months
- Having undergone gastric surgery
- Having enteral nutrition at present
- The patients will come from the HIUNJ of Madrid.
- Currently taking CFTR modulators
Trial locations and contacts
1 site in 1 country.
Spain1 site
Escuela de Doctorado e Investigacion, Universidad Europea
Villaviciosa de Odón, 28670
About this study
Official title: Effects of Exercise With or Without Electrical Stimulation in Physical Fitness in Cystic Fibrosis: an Integrated Vision (ECOMIRIN Study)
This study aims to assess the effects of programmed exercise with or without electrical stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two interventions with a control group.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- Exercise-NMES, Exercise-No NMES
- Keywords
- Cystic Fibrosis, Electrostimulation, Combined Training, Physical Fitness
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-NMESBehavioural
Exercise-NMES
Exercise-No NMESBehavioural
Exercise-No NMES
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle. |
| Exercise-No NMES | Experimental | This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle.
The exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions. Receives: Behavioral: Exercise-No NMES |
| Exercise-NMES | Experimental | This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle.
The exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions. Additionally, this group will receive neuromuscular electrical stimulation (NMES) concomitant to the strength training. Receives: Behavioral: Exercise-NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Strength
Changes in strength will be measured using a five repetition maximum test (5RM)
Measured: Two assessment points throughout the study: baseline and 8 weeks after the intervention
Secondary outcomes (5)
Change in Cardiorespiratory Fitness
Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Measured: Two assessment points throughout the study:baseline and 8 weeks after the intervention
Changes in Pulmonary Function
Changes in pulmonary function will be measured using Spirometry
Measured: Two assessment points throughout the study:baseline and 8 weeks after the intervention
Changes in physical activity levels
Changes in physical activity levels will be measured using Physical Activity Questionnaire for Children and Adolescents (PAC-C or PAC-A)
Measured: Two assessment points throughout the study:baseline and 8 weeks after the intervention
Change in quality of life
Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R)
Measured: Two assessment points throughout the study:baseline and 8 weeks after the intervention
Food consumption frequency
The food consumption frequency will be measured using food frequency questionnaire (FFQ)
Measured: One assessment point at baseline:baseline and 8 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start15 Jan 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margarita Perez, Universidad Europea de Madrid
- Investigators
- Margarita Perez Ruiz, MD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153669
- Sponsor's protocol ID
- R-0019/18
- Acronym
- ECOMIRIN
- Status last verified
- Jul 2020
- First submitted
- 30 Oct 2019
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise With or Without Electrical Stimulation in Physical Fitness in Cystic Fibrosis: an Integrated Vision (ECOMIRIN Study)
- ClinicalTrials.gov ID
- NCT04153669
- Acronym / sponsor ID
- ECOMIRIN / R-0019/18
- Conditions
- Cystic Fibrosis in Children
- Keywords
- Cystic Fibrosis, Electrostimulation, Combined Training, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- 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 study aims to assess the effects of programmed exercise with or without electrical stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two interventions with a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle. |
| Exercise-No NMES | Experimental | Behavioral: Exercise-No NMESThis group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle. The exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions. |
| Exercise-NMES | Experimental | Behavioral: Exercise-NMESThis group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle. The exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions. Additionally, this group will receive neuromuscular electrical stimulation (NMES) concomitant to the strength training. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of CF
- Age: 6-18 years old
- Signature of informed consent of legal guardian and patient.
Key exclusion criteria (6 listed)
- Being a smoker
- Having had an exacerbation in the last 3 months
- Having undergone gastric surgery
- Having enteral nutrition at present
- The patients will come from the HIUNJ of Madrid.
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 |
|---|---|---|
| Exercise-NMESExercise-NMES | Behavioural | Exercise-NMES |
| Exercise-No NMESExercise-No NMES | Behavioural | Exercise-No NMES |
Primary outcome
Change in Strength
Time frame: Two assessment points throughout the study: baseline and 8 weeks after the intervention
Changes in strength will be measured using a five repetition maximum test (5RM)
5 secondary outcomes
Change in Cardiorespiratory Fitness
Time frame: Two assessment points throughout the study:baseline and 8 weeks after the intervention
Changes in Pulmonary Function
Time frame: Two assessment points throughout the study:baseline and 8 weeks after the intervention
Changes in physical activity levels
Time frame: Two assessment points throughout the study:baseline and 8 weeks after the intervention
Change in quality of life
Time frame: Two assessment points throughout the study:baseline and 8 weeks after the intervention
Food consumption frequency
Time frame: One assessment point at baseline:baseline and 8 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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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.
Margarita Perez Ruiz, MD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-NMES and Exercise-No NMES in people with Cystic Fibrosis in Children, run by Universidad Europea de Madrid at 1 site in Spain.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Strength (time frame: Two assessment points throughout the study: baseline and 8 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2020.