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
Secondary identifying numbers	PV3689

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Christoph Heesen
Scientific

Martinistrasse 52
Hamburg
20246
Germany

Email	heesen@uke.de

Study information

Study design	Randomised controlled trial with wait list control group
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/08/2011
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	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

Martinistrasse 52

Hamburg
20246
Germany

Sponsor information

Institute for Neuroimmunology and Clinical Multiple Sclerosis Research (Germany)
Research organisation

Falkenried 94
Hamburg
20251
Germany

Website	http://www.zmnh.uni-hamburg.de/martin/main.php

Funders

Funder type

University/education

Institute for Neuroimmunology and Clinical Multiple Sclerosis Research, University Hospital Hamburg-Eppendorf (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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