The main objective of this pilot study is to explore the changes in physical fitness in patients with MS or SCI who participate in this training program. Secondary, we will explore the changes in walking efficiency, fatigue, quality of life, and theā¦
ID
Source
Brief title
Condition
- Other condition
- Demyelinating disorders
Synonym
Health condition
incomplete dwarslaesies
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters: Primary parameters are:
- aerobic capacity (progressive cardiopulmonary exercise test)
- physical performance (Stair Climb Test, Progressive Isoinertial Lifting
Evaluation, Sit To Stand test, Timed-up-and-Go test, 6 minute walk test maximal
distance).
Secondary outcome
Secondary parameters are:
- maximal muscle strength (1RM handgrip, 1RM legpress),
- walking efficiency (6 minute walk test at comfortable speed),
- fatigue (Fatigue Severity Scale (FSS),
- quality of life (Short Form (36) Health Survey (SF-36), and Multiple
Sclerosis Impact Scale (MSIS-29)),
- feasibility of the program (questionnaire developed for this study).
*
Background summary
In neurorehabilitation, Multiple Sclerosis (MS) and Spinal Cord Injury (SCI)
are highly prevalent conditions. It has been shown that these patients often
have a reduced fitness level and experience severe fatigue, which interferes
with many aspects of daily life functioning. However, the effects achieved with
training programs in people with MS and SCI are generally heterogeneous, not
large, do not lead to reduction of fatigue, or are not extensively studied.
Libra Rehabilitation & Audiology developed an innovative whole-body training
program, aimed at improving fitness using mainly functional exercises, three
types of strength training with free weights, cardio training and functional
skills training. We expect this training program to lead to improvements in
fitness in people with MS or incomplete SCI, resulting in improvements in
fatigue and quality of life.
Study objective
The main objective of this pilot study is to explore the changes in physical
fitness in patients with MS or SCI who participate in this training program.
Secondary, we will explore the changes in walking efficiency, fatigue, quality
of life, and the feasibility of the program.
Study design
This study is an observational cohort pilot study. Patients will participate in
this innovative training program. One week before (pre-treatment), one week
after (post-treatment) and eight weeks after (follow-up) the training program
participants will be tested.
The training program (intervention) consists of: three weeks of observation
period, 12 weeks training period, following a follow-up period of 8 weeks. The
training period consists of three days per week cardio training, strength
training, functional skills training, and once a week physiotherapy. Finally, a
total of three consults at the Sportloket will be conducted, to maintain
physical activity after the training program.
Study burden and risks
Participants will follow the innovative training program as usual care, because
this is since two years the regular rehabilitation protocol at Libra
Rehabilitation & Audiology, location Blixembosch. The training program consists
of the 12 week training program as described above. Extra burden will be the
three assessments, consisting of 1) progressive cardiopulmonary exercise test
including respiratory exchange analysis, 2) 6 minute walking test (comfortable
speed) including respiratory exchange analysis, 3) physical performance tests,
4) maximal muscle strength tests (handgrip and leg press), 5) questionnaires:
Fatigue Severity Scale (FSS), Short Form Survey 36 (SF-36) and a questionnaire
developed to test feasibility (maintaining physically active, possible negative
effects (e.g. injuries, overtraining), time schedule, intensity, and
experiences during the training) for both MS and SCI. In addition, we will use
the Multiple Sclerosis Impact Scale (MSIS-29) in participants with MS.
Assessments have a duration of two and a half hours per patient, resulting in a
total of seven and a half hour for three assessment periods. Assessments
periods will be conducted over three days and in consideration of sufficient
rest periods. The research group has experience in previous projects with
similar assessments (Learn to Move (cerebrale parese): MEC-2009-079;
Subarachnoidale Bloeding: MEC-2008-288; Neuro-oncologie: MEC 2015-577).
Furthermore, Libra Rehabilitation & Audiology has extensive experience with
this innovative training program and physical fitness tests. A strict protocol
is applied to ensure safety of testing.
Toledolaan 2
Eindhoven 5629CC
NL
Toledolaan 2
Eindhoven 5629CC
NL
Listed location countries
Age
Inclusion criteria
Multiple Sclerosis (MS)
-EDSS * 6.5 (needs mainly support on two sides or support tools to walk 20 meters (EDSS <= 6.5), or performs better physically);
-Age * 18 years;;Spinal Cord Injury (SCI)
-WISCI-II score * 1 (ambulates in parallel bars, with braces and physical assistance of two persons, less than 10 meters (WISCI-II <= 1), or performs better physically);
-Age * 18 years;
Exclusion criteria
- Contra-indications to perform a progressive cardiopulmonary exercise test (CPET) (Lausanne protocol );
- Abnormalities detected during the CPET which contra-indicate high intensity physical activities;
- Pregnancy;
- Unable to complete the full intervention based on time investment;
- Essential changes in medication during the intervention period (e.g. disease-modifying drugs in MS);
- Use of beta-blockers;
- MS Relapse during the intervention period;
- Malignant tumor as cause of SCI;
- Any premorbid (before diagnosis of MS/SCI) progressive neuromuscular or brain disease.
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 | NL64522.078.18 |