Condition category
Nervous System Diseases
Date applied
06/10/2011
Date assigned
12/12/2011
Last edited
28/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24158978

Publication citations

  1. 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.

Additional files

Editorial Notes