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van CCT (UK)

van CCT (UK)


- candidate number8257
- NTR NumberNTR2424
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jul-2010
- Secondary IDsNL3218307810 CCMO
- Public TitleAct-Active.
- Scientific TitlePromoting physical activity in individuals with spinal cord injury.
- ACRONYMAct-Active
- hypothesisThe general objective of this project is to evaluate, for persons with a SCI, on the short and long term, the added value of a behavioural focused intervention, on top of a physical exercise intervention, on the level of everyday physical activity. To obtain insight in the working mechanisms of the intervention the study will specifically focus on the role of (changes in) physical activity level and fitness level for patient well-being. We hypothesize that the combination of a behavioural and physical exercise intervention will lead to larger improvements in activity level compared to only physical exercise. The addition of a behavioural intervention is expected to be crucial for the maintenance of effects after discharge from the rehabilitation center.
- Healt Condition(s) or Problem(s) studiedSpinal cord lesion
- Inclusion criteriaPersons are eligible for inclusion if they are able to perform the handcycle training, are between 18 and 65 years of age, have sufficient comprehension of the Dutch language to understand the purpose of the study and its testing methods, and do not have a progressive disease or a psychiatric condition that may interfere with participation.
- Exclusion criteriaPersons are excluded from the study if they have cardiovascular contraindications for exercise, a resting diastolic blood pressure greater than 90mmHg or a systolic blood pressure greater than 180mmHg, severe overuse injuries of the upper extremity, neck or back, and other medical conditions for which maximal effort is not desirable. A medical doctor will check for contraindications when a patient meets the inclusion criteria and is considering participation in the study. Persons who have a prognosis of becoming mainly ambulatory will be excluded. Persons who expect to be unable to come to the rehabilitation center for testing during outpatient rehabilitation will not be included in the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2010
- planned closingdate6-jul-2012
- Target number of participants60
- InterventionsThe intervention will start 2 months before discharge from the rehabilitation center. Subjects will be randomized into two groups (FIT and Behave+FIT). Both groups receive an exercise intervention and sports advice during inpatient rehabilitation. The Behave+FIT group (n=30) in addition will receive a behavioural intervention from the last 2 months before discharge till 6 months after discharge from the rehabilitation center. The exercise intervention consists of a handcycle training program aimed at increasing physical fitness (24 sessions). Sports advice consists of informing about sport possibilities and giving the opportunity to try different kinds of sports at the rehabilitation center or accompanying when visiting another sports center. The behavioural intervention consists of individual counseling on movement behaviour (everyday physical activity and sports) based on motivational interviewing (total of 13 sessions). The behavioural intervention includes setting up action plans and coping strategies and giving feedback by using cycle counters which can register the amount of kilometres travelled with a wheelchair. Moreover, the intervention includes a home visit and additional information will be provided about relevant topics related to physical activity such as barriers and facilitators and health benefits.
- Primary outcomeThe evaluation will primary contain objectively measured level of everyday physical activity (accelerometry-based activity monitor during 5 days).
- Secondary outcomeSecondary parameters are:
2. Subjectively measured level of everyday physical activity (questionnaire);
2. Physical fitness (aerobic capacity);
3. Anthropometry (body mass index and waist circumference);
4. Metabolic fitness (blood pressure, biochemical markers).

Questionnaires will be used to assess functionality, fatigue, secondary problems, pain, social and sports participation, quality of life, self-efficacy, attitude, coping, and depression.
- TimepointsMeasurements will be performed in both the FIT and Behave+FIT group at the beginning of the intervention period (T1), at discharge from the rehabilitation center (T2), 6 months after discharge (T3), and 1 year after discharge (T4).
- Trial web site
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD22-jul-2010 - 30-jul-2010

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