The primary aim of this pilot study is to evaluate the feasibility of the study protocol. The ACTIVATE-CF protocol will be judged feasible when at least 75% of the included patients can comply to the study protocol (with regard to both the…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this pilot study is to evaluate the feasibility of the study
protocol. The ACTIVATE-CF protocol will be judged feasible when at least 75% of
the included patients can comply to the study protocol (with regard to both the
intervention and the control group).
Moreover, at least 75% of the intervention group has to succeed to increase
their physical activity levels, so that they engage in a minimum of 3 hours of
at least moderate activity per week.
Secondary outcome
Secondary outcomes of this study will be:
- Difference between reported quality of life (CFR-Q scores) from baseline to
6 months in the intervention group compared to controls
- Difference between the changes in FEV1 (in% predicted) from baseline to 6
months in the intervention group compared to controls.
- FVC (% predicted) and RV/TLC (%)
- Differences between the changes in reported physical activity (with the HAES
questionnaire) from baseline to 6 months in the intervention group compared to
controls.
- Difference between reported fatigue (CIS-20 and only for the pediatric
subjects, PedsQL fatigue scores) from baseline to 6 months in the intervention
group compared to controls
- Differences between reported levels of stress, anxiety and depression (DASS
scores) from baseline to 6 months in the intervention group compared to
controls.
- Difference between VO2peak (%predicted) from baseline to 6 months in the
intervention group compared to the controls
- Difference between maximal aerobic power (Wmax, %predicted) from baseline to
6 months in the intervention group compared to the controls
We further intend to assess the persistence of behavioral changes and benefits
from the intervention once the supervision is largely withdrawn.
Background summary
Physical activity and exercise have become an accepted and valued component of
Cystic Fibrosis. Regular physical activity and exercise can slow the rate of
decline of pulmonary function, improve physical fitness, and enhance quality of
life. However, motivating people to be more active is challenging.
Supervised exercise programs are expensive and labor intensive, and adherence
falls off significantly once supervision ends. Unsupervised or partially
supervised programs are less costly and more flexible, but compliance can be
more problematic.
Study objective
The primary aim of this pilot study is to evaluate the feasibility of the study
protocol. The ACTIVATE-CF protocol will be judged feasible when at least 75% of
the included patients can comply to the study protocol (with regard to both the
intervention and the control group). Moreover, at least 75% of the intervention
group, has to succeed to increase their physical activity levels.
Study design
In this feasibilty study, a monocenter, randomized controlled trial protocol
with a parallel group design, will be tested. The intervention will have a
partially supervised phase lasting 6 months, followed by a phase were
supervision is largely withdrawn (i.e., the intervention group will continue to
have access to some items of the intervention but will not receive counselling
or additional motivation by members of their centre*s team). After the 6-months
study period, key components of the intervention (pedometers, web-based log,
counselling) will be offered to the controls. Thus, the controls are not
obliged to follow the 'active' intervention and the data of this 'active'
periode will not be included for the data process. No cross over design is
adressed.
Intervention
A total of 20 patients with CF, of at least 12 years of age, with a FEV1 *35%
predicted will be randomised. Following baseline assessment patients will be
randomized into an intervention and a control group. Thereafter, they will be
seen every 3 months for assessments for one year (4 follow-up visits). Along
with individual counseling to increase vigorous physical activity by at least 3
hours per week on each clinic visit, the intervention group will document daily
exercise and inactivity time and will receive a step counter and they will
record their progress with a web-based program. They will also receive monthly
phone calls from the study staff during the first 6 months of the study. After
6 months, they will continue with the step counter and web-based program for a
further 6 months. The control group will receive standard care and keep their
activity level constant during the study period. After 6 months, they will
receive the intervention (not obligatory).
Study burden and risks
As the participants already visit the centre/clinic for their regularly CF
checkups/ clinical visit as well and the same tests are be performed during
these visits, the participants only experience burden due to the
questionnaires, the additional exercise test and the activity interview.
As regard to the intervention, the intervention group will spend minimally 3
hours per week more to (moderate/vigorous) physical activities. Logically,
physical activity is associated with risk to injury, but the physical
therapist/ exercise physiologist will attempt to keep this risk as low as
possible by providing appropriate advice and exercises/activities.
Lundlaan 6
Utrecht 3584AB
NL
Lundlaan 6
Utrecht 3584AB
NL
Listed location countries
Age
Inclusion criteria
* CF based on either two CF-causing mutations and/or a sweat chloride concentration during two tests of >60 mmol/l.
* Age * 12 years
* FEV1 * 35% predicted (based on the equations published by Stanojevic et al. 2008)
* Access to the internet
Exclusion criteria
* Participation in another clinical trial up to 4 weeks prior to the first baseline visit
* Pregnancy/Breastfeeding
* Status post lung transplantation
* Inability to exercise
* More than 4 hours of reported strenuous physical activities per week currently or up to 3
months prior to baseline measurements and not already planned within the coming 6
months.
* Unstable condition affecting pulmonary function or exercise participation (i.e., major
hemoptysis or pneumothorax within the last 3 months, acute exacerbation and ivantibiotics
during the last 4 weeks, unstable allergic bronchopulmonary aspergillosis,
planned surgery, listed for lung transplantation, major musculoskeletal injuries such as
fractures or sprains during the last 2 months, others according to the impression of the
doctor)
* Cardiac arrhythmias with exercise
* Requiring additional oxygen with exercise
* Recent diagnosis of diabetes 3 months prior to or at screening
* Recent changes in medication 1 month or less prior to screening (systemic steroids,
ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline)
* At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or
planned stop of ivacaftor during the trial
* Colonization with Burkholderia cenocepacia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51804.041.15 |