1) To study the prevalence of secondary health conditions in persons with long-term SCI. It is hypothesized that longer duration of injury is associated with a higher prevalence of secondary health conditions.2) To explore the impact of secondary…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The overall aim of this study is to assess the prevalence of long-term
secondary health conditions in persons with SCI for at least ten years.
The secondary health conditions that will be evaluated are: bladder- and bowel
disorders, pressure sores, spasticity, sexual function deficits, cardiovascular
diseases, respiratory problems and (chronic) pain. A comprehensive anamneses
(including spirometry and blood pressure measurement) on these secondary
conditions will be performed. In addition, self-report measures on specific
secondary health conditions will be administered in a mailed questionnaire.
Secondary outcome
The main secondary parameters are related to the impact of the long-term
secondary health conditions and poor fitness on quality of life. For this the
degree of active lifestyle, activity limitations, participation, (wheeled)
fitness and overall well-being will be measured (components of the concept
*quality of life*).
• Active lifestyle will be measured with the Physical Activity Scale for
Individuals with Physical Disabilities (PASIPD).
• Activity limitations will be evaluated with two measures: the Spinal Cord
Independence Measure version III (SCIM-III) for defining limitations in
self-care and mobility and the Wheelchair circuit for assessing wheelchair
skills/capacity.
• Participation will be measured with the Utrecht Scale for Evaluation of
Rehabilitation-Participation (USER-P).
• Fitness is measured with the wheelchair submaximal and maximal exercise test.
• Fatigue will be measured with the Fatigue Severity Scale (FSS).
• Mood will be measured with the Mental Health Inventory-5 (MHI-5).
• Overall well-being will be measured with the World Health Organization
Quality of Life-5 (WHOQOL-5).
Background summary
Many individuals with long-term spinal cord injury (SCI) show, according to the
literature, a serious inactive lifestyle, associated with poor fitness and
secondary health conditions (e.g. bladder- and bowel disorders, pressure sores,
upper-extremity pain, obesity, diabetes, respiratory problems and
cardiovascular disease). This all results in reduced participation and quality
of life. Avoiding this downward spiral, that threatens persons aging with SCI,
is crucial.
International clinical guidelines (Consortium Spinal Cord Medicine) support
long-term follow-up of persons with SCI, but this is not regular practice in
the Netherlands. No systematic Dutch rehabilitation aftercare system with
regular check-ups is operational.
To make the first steps towards the design of a structured and regular
rehabilitation aftercare system for persons with long-term SCI in the
Netherlands we have got to understand the underlying processes of
de-conditioning and secondary health conditions. That will help us to define
the components of a rehabilitation aftercare system that covers the lifespan
and preserve functioning of persons with long-term SCI.
Study objective
1) To study the prevalence of secondary health conditions in persons with
long-term SCI. It is hypothesized that longer duration of injury is associated
with a higher prevalence of secondary health conditions.
2) To explore the impact of secondary health conditions on active lifestyle,
fitness, participation and overall well-being in persons with long-term SCI. It
is hypothesized that people with more severe secondary health conditions will
show a less active lifestyle and lower levels of participation, fitness and
well-being.
Study design
This will be a time since injury (TSI)-stratified cross-sectional study among
300 persons with long-term SCI. Strata of TSI will be 10-20 years, 20-30 years
and more than 30 years after SCI.
This study will consist of a single aftercare check-up which will consist of
anamnesis and physical examination by a rehabilitation physician, an interview
by a research assistant, exercise and laboratory testing, rest-ECG, spirometry
and imaging of the bladder and kidneys by an ultrasound. All these parts of the
study will only take place once.
Eight Dutch rehabilitation centers (RC*s) with a SCI unit will participate in
this study.
Study burden and risks
Participants may experience local upper extremity discomfort during the
exercise test. The risks during the test are relatively low because of thorough
screening prior to participation, monitoring possible complaints during testing
and safety precautions throughout testing.
Cardiovascular contra-indications for exercise testing will be evaluated for
each participant according to the American College of Sports Medicine
guidelines. Persons with cardiovascular contra-indications will not participate
in the exercise test.
The identification of persons with long-term SCI suffering from secondary
complications and/or de-conditioning allows us to refer these persons to other
health professionals of to keep them in consultation. This may benefit these
persons for the long-term by receiving new or modified treatment.
The expected beneficial effects for the study population in the long-term in
combination with the very limited risks would justify the execution of the
purposed study.
Rembrandtkade 10
3583 TM Utrecht
NL
Rembrandtkade 10
3583 TM Utrecht
NL
Listed location countries
Age
Inclusion criteria
• Spinal cord injury;
• Age between 28-65 years;
• Age at injury between 18 and 35 years;
• Time since injury: at least 10 years;
• Wheelchair dependent (hand rim propelled wheelchair or electric wheelchair), at least for longer distances;
Exclusion criteria
Overall exclusion criterion:
• Insufficient mastery of the Dutch language to respond to an oral interview and test instructions.;Exclusion criteria for participation in the exercise test:
- cardiovascular comorbidity: in accordance with the guidelines of the American College of Sports Medicine (ACSM) (see our research protocol).
- Temporary contra-indications: decubitus or an infection with fever.
- Bloodpressure: diastolic bloodpressure at rest > 90 mmHg or a systolic bloodpressure at rest > 180 mmHg.
- Serious musculoskeletal complaints of the upper extremities, neck or back.
- rest-ECG abnormalities:
P wave:
o Left atrial enlargement: negative portion of the P wave in lead V1 >= 0.1mV in depth and >= 0.04s in duration;
o Right atrial enlargement: peaked P wave in leads II and III or V1 >= 0.25mV in amplitude.
QRS complex:
o Frontal plane axis deviation: right >= + 120° or left -30° to -90°;
o Increased voltage: amplitude of R or S wave in a standard lead >= 2mV, S wave in lead V1 or V2 >= 3mV, or R wave in lead V5 or V6 >= 3mV;
o Abnormal Q waves >= 0.04s in duration or >= 25% of the height of the ensuing R wave or QS pattern in two or more leads;
o Right or left bundle branch block with QRS duration >= 0.12s;
o R or R* wave in lead V1 >= 0.5mV in amplitude and R/S ratio >= 1.
ST-segment, T-waves, and QT interval:
o ST-segment depression or T-wave flattening or inversion in two or more leads;
o Prolongation of heart rate corrected QT interval >= 0.44s in males and > 0.46s in females.
Rhythm and conduction abnormalities:
o More than one premature ventricular beat or more severe ventricular arrhythmias;
o Supraventricular tachycardias, atrial flutter, or atrial fibrillation;
o Short PR interval (< 0.12s) with or without *delta* wave;
o Sinus bradycardia with resting heart rate <= 40 beats/min;
o First (PR >= 0.21s), second or third degree atrioventricular block.
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 | NL36394.041.11 |