Aerobic exercise to improve fitness, walking ability and cognitive function in multiple sclerosis: a randomized controlled trial
| ISRCTN | ISRCTN76467492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76467492 |
| Protocol serial number | PV3689 |
| Sponsor | Institute for Neuroimmunology and Clinical Multiple Sclerosis Research (Germany) |
| Funder | Institute for Neuroimmunology and Clinical Multiple Sclerosis Research, University Hospital Hamburg-Eppendorf (Germany) |
- Submission date
- 06/10/2011
- Registration date
- 12/12/2011
- Last edited
- 28/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
Martinistrasse 52
Hamburg
20246
Germany
| heesen@uke.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial with wait list control group |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Hamburg Pilot Trial on Exercise in Secondary Progressive Multiple Sclerosis (HAPITEX-SPMS) |
| Study acronym | HAPITEX-SPMS |
| Study objectives | 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(s) | Medical Board Hamburg, Germany, 1 August 2011, ref: PV3689 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Physical fitness pre and post intervention as determined by a standardized ergometer test |
| Key secondary outcome measure(s) |
1. Walking ability (6-minute walk test) |
| Completion date | 31/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Patients with secondary-progressive multiple sclerosis (MS) 2. Disease duration <20 years 3. Expanded disability status scale (EDSS) 4-6 |
| Key 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) |
| Date of first enrolment | 01/08/2011 |
| Date of final enrolment | 31/01/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
20246
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
