Aerobic exercise to improve fitness, walking ability and cognitive fun
Hamburg Pilot Trial on Exercise in Secondary Progressive Multiple Sclerosis (HAPITEX-SPMS)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
Physical fitness pre and post intervention as determined by a standardized ergometer test
Physical function
Other measures (1)
1. Walking ability (6-minute walk test) 2. Cognitive function (assessed by a neuropsychological battery including learning and memory, attention, executive function and processing speed) 3. Depression (IDS-30R) 4. Fatigue (MFIS) Assessed pre and post intervention.
Thinking and memoryFatigueWalking and mobilityMood and sleep
Who could take part
Progressive MS · EDSS 4 to 6
Show the full criteria
Inclusion criteria
Inclusion: 1. Patients with secondary-progressive multiple sclerosis (MS) 2. Disease duration <20 years 3. Expanded disability status scale (EDSS) 4-6 Exclusion: 1. Immunomodulatory therapy in the last 3 months 2. Steroid therapy in the last 4 weeks 3. Relapsing-remitting or primary progressive MS 4. Laboratory markers of liver and kidney function outside of the normal range 5. Immunodeficiency or other serious medical illnesses (based on the judgement of the physician) 6. Hepatitis B or hepatitis C infection or other chronic liver diseases 7. Patients taking psychoactive medication (benzodiazepines, neuroleptics, antidepressants)
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims: Several studies have shown that fitness training can increase well-being and quality of life in patients with multiple sclerosis. However, most of the available studies have included patients during the early phase of disease with mild to moderate disability. In this study, we investigated if standardized fitness training is possible for patients with progressive disease and which training form may be most suitable for this group. In addition, we will explore if exercise can enhance physical fitness, walking ability and cognitive function (e.g. memory). Who can participate? Male or female patients aged 30 60 years with secondary-progressive multiple sclerosis and an Expanded Disability Status Scale (EDSS) between 4 and 6. What does the study involve? The patients were randomly allocated to one of three different groups of fitness training or to a wait list control group (where these patients would have to wait to receive the fitness training). All patients in the three fitness training groups will exercise for approximately 30-45 minutes, 2 or 3 times a week, for 8 weeks. The intensity of the training was adjusted to their individual fitness level which was assessed at the initial fitness evaluation at the Department of Sports Medicine. The patients in the wait list control group will be offered an 8 week exercise training program of their choice free of charge after the study is completed. What are the possible benefits and risks of participating? Participants could increase their level of physical fitness under medical supervision. However exercise may lead to an increase of some symptoms of multiple sclerosis due to increases in body temperature while exercising. Where is the study run from? University Hospital Hamburg-Eppendorf, Hamburg, Germany When is the study starting and how long is it expected to run for? The study started in August 2010 and ended in January 2012. Who is funding the study? University Hospital Hamburg-Eppendorf, Germnay Who is the main contact? Prof Christoph Heesen heesen@uke.de
Papers
Results
results
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History
Started
Aug 2011
Finished
Jan 2012