search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Nutritional status, vulnerability and disability in COPD patients


- candidate number21825
- NTR NumberNTR5107
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2015
- Secondary IDs2014/432 Medisch Ethische Toetsingscommissie UMC Groningen
- Public TitleNutritional status, vulnerability and disability in COPD patients
- Scientific TitleDisease-related Malnutrition, Frailty and Disability, Relations and Clinical Outcome in COPD patients
- ACRONYM
- hypothesisFrailty is considered to be a clinical state in which there is an increase in an individual’s vulnerability for developing increased dependency and/or mortality when exposed to a stressor (Morley, Vellas et al. 2013). Frailty is a strong predictor for the adverse clinical outcome of disability. This is an individual problem, but also very relevant to society; people are getting older but not necessarily in an independent and healthy way. The complex interactions between factors of the multidimensional and dynamic concept of frailty remain to be clarified (de Vries, Staal et al. 2011). Since malnutrition has such an impact on physical performance, frailty and malnutrition are suspected to correlate firmly. Knowing in what way these conditions influence each other is extremely important in achieving to revolve the process of becoming frail and disable. The main objective of this study is to investigate whether changes in nutritional status correlate to changes in frailty status, and whether these changes impact on disability as a clinical outcome in patients with a chronic obstructive pulmonary disease. The secondary objective is to explore adaptive strategies for dietary challenges in patients with chronic obstructive pulmonary disease, and thus identify predictors of dietary resilience, and dietary resiliency subsequently.
- Healt Condition(s) or Problem(s) studiedMalnutrition, Frailty, Disability
- Inclusion criteriaAged 40 years or older
Able to understand and speak the Dutch language
Diagnosed with COPD by a pulmonary physician
Attending the full rehabilitation program
- Exclusion criteriaWheel chair dependency
Any contra-indication for physical exercise
Severe cognitive disabilities
Skin allergy or highly sensitive skin
Palliative treatment
Pacemaker
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 30-mrt-2015
- planned closingdate31-jul-2018
- Target number of participants86
- InterventionsThis study will be conducted in adult patients with chronic obstructive pulmonary disease following a rehabilitation program of 9 weeks. The sample will be stratified according to nutritional status classified by PG-SGA category A, B or C (classification A (well nourished), B (moderately malnourished or risk for malnutrition) or C (severely malnourished) to assure an adequate level of distribution in the domain of malnutrition in the study population.
- Primary outcomedisease-related malnutrition
frailty
disability
- Secondary outcomedietary intake
physical activity
body composition
physical functioning
clinical outcome
- TimepointsPatients will be assessed 3 times during their 9 weeks of rehabilitation (begin, middle and end) and 4 times in follow-up setting (3 months, 6 months, one year and two years after finishing the rehabilitation program)
The following measures (tests and questionnaires) will be performed on every occasion: body weight, length, accelerometer, mid upper arm circumference and triceps skinfold, bio-electrical impedance analysis (including vector analysis), muscle ultrasound scan, handgrip strength, gait speed, Short Physical Performance Battery, muscle tone, PG-SGA©, MNA®, EFIP, GFI, Fried’s criteria, WHODAS 2.0, food diary.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Lies ter Beek
- CONTACT for SCIENTIFIC QUERIES Harriët Jager-Wittenaar
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Living Lab (Innovatiewerkplaats), Clinical Malnutrition, part of Centre of Expertise Healthy Ageing
- Publications
- Brief summaryThis study will take place in the Netherlands.
Frailty is a strong predictor for the adverse clinical outcome of disability. The complex interactions between factors of the multidimensional and dynamic concept of frailty remain to be clarified (de Vries, Staal et al. 2011). Since malnutrition has such an impact on physical performance, frailty and malnutrition are suspected to correlate firmly. Knowing in what way these conditions influence each other is extremely important in achieving to revolve the process of becoming frail and disable.
The main objective of this study is to investigate whether changes in nutritional status correlate to changes in frailty status, and whether these changes impact on disability as a clinical outcome in patients with a chronic obstructive pulmonary disease. The secondary objective is to explore adaptive strategies for dietary challenges in patients with chronic obstructive pulmonary disease, and thus identify predictors of dietary resilience, and dietary resiliency subsequently.
- Main changes (audit trail)
- RECORD26-mrt-2015 - 26-apr-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl