The primary aim of this phase II trial is to assess whether a progressive resistance training program can slow down neurodegeneration in people with PMS. Additional objectives of this study are: 1. To determine the effect of exercise on disability.…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of this study is neurodegeneration, primarily
operationalized by brain atrophy on brain MRI
Secondary outcome
Secondary outcome parameters will include disability parameters and
cardiovascular risk profile.
Background summary
To date there are little to no disease modifying treatment options for people
with progressive multiple sclerosis (PMS). Neurodegeneration, rather than
inflammation, seems to play a key role in the progressive phase of MS. Evidence
from animal models and healthy aging individuals suggests that exercise (e.g.
resistance training and endurance training) might be a possible therapy
affecting neurodegeneration. However, neuroprotective effects of exercise
interventions have not been examined yet in PMS and the possible mode of action
of these effects needs to be elucidated.
Study objective
The primary aim of this phase II trial is to assess whether a progressive
resistance training program can slow down neurodegeneration in people with PMS.
Additional objectives of this study are: 1. To determine the effect of exercise
on disability. 2. To explore the relationship between disability and
neurodegeneration. 3. To determine the effect of exercise on cardiovascular
risk profile. 4. To assess the relative responsiveness of different
neurodegeneration parameters.
Study design
In a phase II clinical trial with an extended baseline, 30 patients with PMS
will be assigned to progressive resistance training (PRT). The duration of the
study is 48 weeks, consisting of 16 weeks baseline (no intervention), 16 weeks
training and 16 weeks follow-up. Due to the extended baseline design patients
are their own control group.
Intervention
participants will be assigned to: 1. A 16-week PRT program, one hour per
training, three times per week focusing on large muscle groups, to improve
muscle strength.
Study burden and risks
Over a period of 48 weeks there will be eight 3-hour measurement sessions.
Blood sampling might be unpleasant and can result in bruising. Physical tests
can result in muscle soreness and fatigue for maximally 48 hours. To reduce
fall-risk during physical tests an experienced assessor will perform
measurements. All measurements have been performed previously in patients with
multiple sclerosis and are safe and feasible. The training interventions are
time consuming, 3-times per week for sixteen weeks. Exercise programs may
result in fatigue and muscle soreness and there are some minor risks of falling
and bruising as is common by doing sports
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Progressive Multiple Sclerosis diagnosis defined as: *definite diagnosis of MS
according to the 2017 McDonald Criteria with gradual progression of
neurological impairments according to the Lublin criteria 2013.*
EDSS Scale 3.5 - 6
Able to participate in the exercise programs, i.e. no contra-indications for
training according to the guidelines of the American college of Sports Medicine
- No history of heart problems
- No symptoms that might indicate heart problems
- No other major health issues
Age between 18 and 70 years old
Able to understand therapists instructions
Fulfilling the safety criteria for magnetic resonance assessment
- No metal inside the body
- Not claustrophobic
- No pregnancy
Exclusion criteria
Diagnosed with primary progressive multiple sclerosis
Relapse within 3 months of baseline visit
Severe comorbidity (Cumulative Illness Rating Scale >= 3 on 1 or more organ
systems).
Initiation of Fampridine within 6 months of baseline visit.
Depression, Hospital Anxiety and Depression Scale score, depression subscale
>=11 (i.e. indicative of clinical anxiety disorder or clinical depression)
Other neurological- and/or musculoskeletal disorders
Already participating in a (guided) high intensity exercise training
Participating in another intervention study
Pregnancy, given birth previous 6 months, or active pregnancy wish
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71762.029.19 |
| Other | NL8265 |