Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Christoph Heesen
ORCID ID
Contact details
Martinistrasse 52
Hamburg
20246
Germany
heesen@uke.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PV3689
Study information
Scientific title
Hamburg Pilot Trial on Exercise in Secondary Progressive Multiple Sclerosis (HAPITEX-SPMS)
Acronym
HAPITEX-SPMS
Study hypothesis
The aim of the study is to investigate the safety and feasibility of exercise in multiple sclerosis (MS) patients with advanced disability. We will also test the potential of standardized exercise interventions to improve physical fitness, enhance cognitive function and decrease fatigue and depression in MS patients with progressive disease.
Ethics approval
Medical Board Hamburg, Germany, 1 August 2011, ref: PV3689
Study design
Randomised controlled trial with wait list control group
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Multiple Sclerosis
Intervention
Subjects are randomly assigned to one of four conditions (biased coin randomization):
1. Bicycle ergometry
2. Hand ergometry
3. Rowing
4. Waitlist control
The goal is to have 10 subjects in each group, 8 weeks with 2-3 sessions per week
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Physical fitness pre and post intervention as determined by a standardized ergometer test
Secondary outcome measures
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.
Overall trial start date
01/08/2011
Overall trial end date
31/01/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with secondary-progressive multiple sclerosis (MS)
2. Disease duration <20 years
3. Expanded disability status scale (EDSS) 4-6
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
40
Participant exclusion criteria
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)
Recruitment start date
01/08/2011
Recruitment end date
31/01/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Martinistrasse 52
Hamburg
20246
Germany
Sponsor information
Organisation
Institute for Neuroimmunology and Clinical Multiple Sclerosis Research (Germany)
Sponsor details
Falkenried 94
Hamburg
20251
Germany
Sponsor type
Research organisation
Website
Funders
Funder type
University/education
Funder name
Institute for Neuroimmunology and Clinical Multiple Sclerosis Research, University Hospital Hamburg-Eppendorf (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24158978
Publication citations
-
Results
Briken S, Gold SM, Patra S, Vettorazzi E, Harbs D, Tallner A, Ketels G, Schulz KH, Heesen C, Effects of exercise on fitness and cognition in progressive MS: a randomized, controlled pilot trial., Mult. Scler., 2014, 20, 3, 382-390, doi: 10.1177/1352458513507358.