Clinical Trial: Armergometry to Improve Mobility in MS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Armergometry to Improve Mobility in Chronic Progressive Multiple Sclerosis

Brief Summary: Chronic progressive multiple sclerosis patients will be randomised to home-based arm ergometry training for 12 weeks or a waitlist control group which will have access after 12 week primary endpoint assessment. Assessments include clinical outcomes and questionnaires as well MRI imaging and transcranial magnetic stimulation paradigms. Primary endpoint will be the 6 minute walking test at week 12.

Detailed Summary:

Short protocol Design: Patients with progressive MS (PPMS, SPMS) and moderate disability (Expanded Disability Status Scale 4-6.5) will be randomized to home-based arm ergometry or a waitlist control group. Home-based training will be supervised by SD-card documentation, telephone, email and personal contact.

Inclusion criteria: clinically definite MS according to Poser (1983), no progression in the last 6 months before starting, no acute relapse, age 18- 65 years, EDSS 4-6.5, able to perform all arm- and handfunctions in daily life, able to execute a daily training Exclusion: medical contraindications for exercise therapy like cardiovascular or major orthopedic disease, metal part in body, substantial cognitive deficit, cardiac pacemaker or other electric implants, pregnancy, epilepsy Recruitment sample: n=50 Participants for analysis: n= 40 Control group: Intervention available after 3 months Duration: 3 months, data acquisition until 12 months after intervention Hypothesis: Arm ergometry improves walking ability (measured by 6-Minute Walk Test, 6MWT). Secondary endpoints include cognition, fatigue, depression, life quality and blood markers as BDNF.

Primary endpoint: Walking ability: Walking ability is evaluated before and after the training program (12 weeks) using the 6MWT by measuring the total walking distance within six minutes.

Secondary endpoints:

  1. Walking abilities: 25FWT, TUG, 5SST, 9HPT, 7-day-accelerometry, MSWS- 12, Walking analysis on Gaitrite tapestry and with kinect camera with different tasks: normal speed, maximal speed, turning around and double tasking
  2. EDSS (Expanded Disability status scale)
  3. Fitness measu
    Sponsor: Universitätsklinikum Hamburg-Eppendorf

    Current Primary Outcome: 6 minute walking test [ Time Frame: 6 min. ]

    maximum distance in 6 minutes


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • accelerometry [ Time Frame: 7 days ]
      walking speed through 7 days
    • verbal learning and memory [ Time Frame: 30 minutes ]
      rapid and delayed recall
    • peak oxygene uptake [ Time Frame: 20 minutes ]
      at step ergometry
    • brain atrophy [ Time Frame: 3 months ]
      based on percentage brain volume chnage through 3 months
    • Brain derived neurotrophic factor [ Time Frame: 3 months change ]
      serum levels


    Original Secondary Outcome: Same as current

    Information By: Universitätsklinikum Hamburg-Eppendorf

    Dates:
    Date Received: March 2, 2017
    Date Started: May 1, 2017
    Date Completion: December 31, 2018
    Last Updated: May 5, 2017
    Last Verified: May 2017