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Aerobic exercise to improve fitness, walking ability and cognitive function in multiple sclerosis: a randomized controlled trial

Hamburg Pilot Trial on Exercise in Secondary Progressive Multiple Sclerosis (HAPITEX-SPMS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76467492
Enrollment
40
Registered
2011-12-12
Start date
2011-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis Nervous System Diseases Multiple Sclerosis

Interventions

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 gr

Sponsors

Institute for Neuroimmunology and Clinical Multiple Sclerosis Research (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with secondary-progressive multiple sclerosis (MS) 2. Disease duration <20 years 3. Expanded disability status scale (EDSS) 4-6

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Physical fitness pre and post intervention as determined by a standardized ergometer test

Secondary

MeasureTime frame
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.

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026