Clinical Trial: Effect of Resistance and Aerobic Exercise in CIDP or MMN

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Resistance and Aerobic Exercise on Muscle Strength, Aerobic Capacity and Quality of Life in Patients Treated With Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Brief Summary:

Resistance and aerobic exercise has been shown to be effective for maintenance of muscle strength in patients with neuromuscular diseases.

Exercise in CIDP and MMN is sparsely described. The aim of the study is to evaluate changes in muscle strength during high intensive resistance training and changes in maximal oxygen consumption (VO2-max) during high intensive aerobic training in patients with CIDP or MMN in maintenance therapy with subcutaneous immunoglobulin.

The hypotheses are that muscle strength and VO2-max are significantly increased during the training sessions.


Detailed Summary:
Sponsor: University of Aarhus

Current Primary Outcome:

  • Changes in isokinetic muscle strength [ Time Frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks ]

    Changes in isokinetic muscle strength during resistance exercise. Four muscle groups bilateral are selected.

    CIDP: Knee flexion/extension Elbow flexion/extension MMN: Elbow flexion/extension Wrist flexion/extension

  • Changes in maximal oxygen consumption (VO2-max) [ Time Frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks ]

    VO2-max are measured during the 12 weeks aerobic exercise session and at enrolment 12 weeks before start of exercise.

    VO2-max are measured while the participant running on a ergometer bicycle by accumulation of exhaled air



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Medical Research Council (MRC) [ Time Frame: -12, 0, 6, 12, 18, 24 weeks ]
  • Change in Overall Disability Sum Score (ODSS) [ Time Frame: -12, 0, 6, 12, 18, 24 weeks ]
  • Change in 6-Minute Walk test [ Time Frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks ]
  • Change in Quality of Life measured by The Short Form (36) Health Survey (SF-36) questionnaire [ Time Frame: -12, 0, 6, 12, 18, 24 weeks ]
  • Change in Fatigue Severity Score (FSS) [ Time Frame: -12, 0, 6, 12, 18, 24 weeks ]


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: February 17, 2014
Date Started: April 2014
Date Completion:
Last Updated: May 11, 2016
Last Verified: August 2015