Cystic FibrosisFKEXNCT02127957
Effects of an Exercise Program Among CF Patients With Dysglycemia
A study testing Exercise in people with Cystic Fibrosis and Cystic Fibrosis Related Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
The objective of the investigators research program is to determine whether a combined exercise program (aerobic and resistance) improves abnormal glucose tolerance and diabetes control in CF patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis Related Diabetes
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Jul 2015
- 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
- Men or women 18 years and older.
- Diagnosis of CF documented.
- Obstructive ventilatory deficit light to moderate , as defined in the guidelines of the ATS / ERS , an FEV / FVC ratio > 70% and ≥ 40% FEV .
- Stable health status, no episode of superinfection in the past 6 weeks.
- Impaired glucose tolerance , glucose > 11.1 mmol / L at the 1st hour of the OGTT or unmedicated CFRD.
- Patients who wants to participate in an exercise program for 12 weeks.
- Sedentary (less than 105 min / week of physical activity ) .
Who cannot join
- Exacerbation of respiratory symptoms with or without hospitalization , or use of oral antibiotics in the last 6 weeks.
- Exacerbation with intravenous antibiotics .
- Severe obstructive deficit as defined by FEV <40% , with an FEV / FVC ratio <70 %.
- Any other disease or condition that may limit exercise performance .
- Without treatment with oral hypoglycemia , insulin, oral anti -inflammatory and other treatments that may influence glucose metabolism (patient under cortef accepted) .
- Hemoptysis ( > 50-60 cc) in the last 6 weeks.
- Desaturation during exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Program of Aerobic and Resistance Exercises Combined in Patients With Cystic Fibrosis (CF) With Impaired Glucose Tolerance or Diabetes Related to CF Without Medication
The objective of the investigators research program is to determine whether a combined exercise program (aerobic and resistance) improves abnormal glucose tolerance and diabetes control in CF patients. This program of exercises to increase strength and muscle endurance, exercise tolerance, will be assessed in a group of 12 CF patients with impaired glucose tolerance. The effect of exercise will be compared with a control group of 12 patients also glucose intolerant but do not participate in structured physical activity program. The duration of the exercise program will be 12 weeks and several measures (glucose tolerance, inflammatory profile, lung function, exercise capacity, muscle strength and endurance) will be conducted pre and post program to assess the program's impact .
Read the detailed description
A total of 24 subjects with CF with impaired glucose tolerance or with diabetes related to CF (CFRD) unmedicated will be recruited. Participants will be recruited through a research nurse in CF , which will analyze the available data to medical records and seek the participation of subjects who meet the inclusion and exclusion criteria . Patients receive during their visit to the outpatient clinic of FK at Hotel -Dieu du CHUM hospital , a inform consent form (ICF) for the study. Their intention to participate and the main inclusion and exclusion criteria will be confirmed in a telephone interview conducted by a member of the team at the IRCM. Finally, during the visit at the IRCM , the subject will get answer to his question for ICF and ICF will be signed before any procedure.
All participants who agree to participate in the research project must undergo a short telephone interview (20 minutes) and 4 assessment visits ( approximately 1-5 hours) Pre (2 visits ) and post (2 visits ) study . The control patients with delayed exercises conduct a further assessment visit at the end of the training.
GROUP 1 EXERCISES : Patients in exercises group will be required to take part of two supervised training sessions and 8 follow up phone call . The exercise program will be performed three times per week for about one hour .
GROUP 2 CONTROL: Participants in the control group will be contacted by phone once a month following entry into the study. On this occasion a reminder to complete the physical activity log will be realized. Following the visit #6 , patients in the control group will be invited to participate in a second study phase to participate in supervised exercise program . This participation will involve an additional 12 weeks of follow-up, which included the same visit as Group 1 with exercises. In this case, to simplify participation and reduce the volume of blood collected , the final visit (#5) of the project will also be the first visit of exercises phase. This part of study, involves 2 supervised training sessions and 8 follow up phone call . The exercises program will be performed three times per week for about one hour .
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Related Diabetes
- Being tested
- Exercise
- Keywords
- cystic fibrosis, exercise, Cystic fibrosis related diabetes
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise will be prescribed by kinesiologist and will be done 3 times a week for 1 hour by subject. Every 4 weeks subject will be on supervised training session.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Exercise group will have 6 visit and 8 phone call. Subject will have to do prescribed exercice for 1h, 3 times a week for 12 weeks. Receives: Other: Exercise |
| Control | No intervention | Control group will have 4 visit and 3 phone call. They will receive standard counselling for exercise in cystic fibrosis, but no prescribed exercice will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemia at 2h of -1.5 mmol/L
Evaluate if patient with CF have improved glucose tolerance at the second hour of a Oral glucose tolerance test (OGTT) following a combined exercise program.
Measured: baseline and week 13
Secondary outcomes (7)
inflammatory marker change
Assess whether the practice of regular combined physical activity program modifies the inflammatory profile (C-reactive protein, cytokines (IL-1β, IL-13, IL-6, IL-8, IL-10, TNF, CH3Li)) associated with CF diabetes.
Measured: baseline and week 13
VO2max changes
Evaluate if regular combined physical activity program improves exercise tolerance in CF patient.
Measured: baseline and week 13
muscular strength
Evaluate if regular combined physical activity program improves muscle strength and endurance.
Measured: baseline and week 13
area under the insulin curve
Evaluate if regular combined physical activity program improves insulin sensitivity.
Measured: basline and week 13
Changes in glycemia of -1.5mmol/L at 1h
Evaluate if regular combined physical activity program improves glucose tolerance at one hour of the OGTT.
Measured: basline and week 13
quality of life changes
Evaluate if regular combined physical activity program improves quality of life in CF.
Measured: baseline and week 13
lean mass changes
Evaluate if regular combined physical activity program improves lean mass in CF.
Measured: basline and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yves Berthiaume, Institut de Recherches Cliniques de Montreal
- Investigators
- Yves Berthiaume, Md, Principal investigator, Institut de Recherches Cliniques de MontrealRemi Rabasa-Lhoret, Md, Study chair, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127957
- Sponsor's protocol ID
- FKEX_12.356
- Acronym
- FKEX
- Status last verified
- Jul 2015
- First submitted
- 18 Apr 2014
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Beaudoin N, Bouvet GF, Coriati A, Rabasa-Lhoret R, Berthiaume Y. Combined Exercise Training Improves Glycemic Control in Adult with Cystic Fibrosis. Med Sci Sports Exerc. 2017 Feb;49(2):231-237. doi: 10.1249/MSS.0000000000001104.
PubMed 27669451
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Program of Aerobic and Resistance Exercises Combined in Patients With Cystic Fibrosis (CF) With Impaired Glucose Tolerance or Diabetes Related to CF Without Medication
- ClinicalTrials.gov ID
- NCT02127957
- Acronym / sponsor ID
- FKEX / FKEX_12.356
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Related Diabetes
- Keywords
- cystic fibrosis, exercise, Cystic fibrosis related diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 May 2014 (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.
The objective of the investigators research program is to determine whether a combined exercise program (aerobic and resistance) improves abnormal glucose tolerance and diabetes control in CF patients. This program of exercises to increase strength and muscle endurance, exercise tolerance, will be assessed in a group of 12 CF patients with impaired glucose tolerance. The effect of exercise will be compared with a control group of 12 patients also glucose intolerant but do not participate in structured physical activity program. The duration of the exercise program will be 12 weeks and several measures (glucose tolerance, inflammatory profile, lung function, exercise capacity, muscle strength and endurance) will be conducted pre and post program to assess the program's impact .
Detailed description
A total of 24 subjects with CF with impaired glucose tolerance or with diabetes related to CF (CFRD) unmedicated will be recruited. Participants will be recruited through a research nurse in CF , which will analyze the available data to medical records and seek the participation of subjects who meet the inclusion and exclusion criteria . Patients receive during their visit to the outpatient clinic of FK at Hotel -Dieu du CHUM hospital , a inform consent form (ICF) for the study. Their intention to participate and the main inclusion and exclusion criteria will be confirmed in a telephone interview conducted by a member of the team at the IRCM. Finally, during the visit at the IRCM , the subject will get answer to his question for ICF and ICF will be signed before any procedure.
All participants who agree to participate in the research project must undergo a short telephone interview (20 minutes) and 4 assessment visits ( approximately 1-5 hours) Pre (2 visits ) and post (2 visits ) study . The control patients with delayed exercises conduct a further assessment visit at the end of the training.
GROUP 1 EXERCISES : Patients in exercises group will be required to take part of two supervised training sessions and 8 follow up phone call . The exercise program will be performed three times per week for about one hour .
GROUP 2 CONTROL: Participants in the control group will be contacted by phone once a month following entry into the study. On this occasion a reminder to complete the physical activity log will be realized. Following the visit #6 , patients in the control group will be invited to participate in a second study phase to participate in supervised exercise program . This participation will involve an additional 12 weeks of follow-up, which included the same visit as Group 1 with exercises. In this case, to simplify participation and reduce the volume of blood collected , the final visit (#5) of the project will also be the first visit of exercises phase. This part of study, involves 2 supervised training sessions and 8 follow up phone call . The exercises program will be performed three times per week for about one hour .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Other: ExerciseExercise group will have 6 visit and 8 phone call. Subject will have to do prescribed exercice for 1h, 3 times a week for 12 weeks. |
| Control | No intervention | –Control group will have 4 visit and 3 phone call. They will receive standard counselling for exercise in cystic fibrosis, but no prescribed exercice will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women 18 years and older.
- Diagnosis of CF documented.
- Obstructive ventilatory deficit light to moderate , as defined in the guidelines of the ATS / ERS , an FEV / FVC ratio > 70% and ≥ 40% FEV .
- Stable health status, no episode of superinfection in the past 6 weeks.
- Impaired glucose tolerance , glucose > 11.1 mmol / L at the 1st hour of the OGTT or unmedicated CFRD.
Key exclusion criteria (7 listed)
- Exacerbation of respiratory symptoms with or without hospitalization , or use of oral antibiotics in the last 6 weeks.
- Exacerbation with intravenous antibiotics .
- Severe obstructive deficit as defined by FEV <40% , with an FEV / FVC ratio <70 %.
- Any other disease or condition that may limit exercise performance .
- Without treatment with oral hypoglycemia , insulin, oral anti -inflammatory and other treatments that may influence glucose metabolism (patient under cortef accepted) .
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 |
|---|---|---|
| ExerciseExercise will be prescribed by kinesiologist and will be done 3 times a week for 1 hour by subject. Every 4 weeks subject will be on supervised training session. | Other | Exercise |
Primary outcome
Change in glycemia at 2h of -1.5 mmol/L
Time frame: baseline and week 13
Evaluate if patient with CF have improved glucose tolerance at the second hour of a Oral glucose tolerance test (OGTT) following a combined exercise program.
7 secondary outcomes
inflammatory marker change
Time frame: baseline and week 13
VO2max changes
Time frame: baseline and week 13
muscular strength
Time frame: baseline and week 13
area under the insulin curve
Time frame: basline and week 13
Changes in glycemia of -1.5mmol/L at 1h
Time frame: basline and week 13
quality of life changes
Time frame: baseline and week 13
lean mass changes
Time frame: basline and week 13
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 31 Jul 2015.
- Derived from this study: PubMed 27669451Beaudoin N, Bouvet GF, Coriati A, Rabasa-Lhoret R, Berthiaume Y. Combined Exercise Training Improves Glycemic Control in Adult with Cystic Fibrosis. Med Sci Sports Exerc. 2017 Feb;49(2):231-237. doi: 10.1249/MSS.0000000000001104.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
Yves Berthiaume, Md principal investigator
Institut de Recherches Cliniques de Montreal
Remi Rabasa-Lhoret, Md study chair
Institut de Recherches Cliniques de Montreal
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 in people with Cystic Fibrosis and Cystic Fibrosis Related Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
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 7 inclusion and 7 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 31 Jul 2015. 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 Canada. 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 glycemia at 2h of -1.5 mmol/L (time frame: baseline and week 13). 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 NCT02127957, which also lists 1 linked publication.
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 31 Jul 2015.