CompletedNot Applicable

Effect of Resistance and Aerobic Exercise in CIDP or MMN

Denmark23 participantsStarted 2014-04

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 and \< 80 years * Diagnosed with definite or probable CIDP or definite or probable MMN fulfilling the European Federation of Neurological Sciences/Peripheral Nerve Society (EFNS/PNS) criteria * Stable maintenance therapy with immunoglobulin (no change of dosage \< 3 months before inclusion) * Duration of CIDP or MMN \> 6 months * Negative result on a pregnancy test (HCG-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study Exclusion Criteria: * Other cause of neuropathy (incl. pressure neuropathy) * Exercise before enrolment (\> 1 hour of exercise per week or \> 4 km bicycling per day) * Walking distance \< 10 meter with or without aid * Diabetes mellitus, severe cardiac or pulmonary disease, malignancies * Known history of adverse reactions to Immunoglobulin A in other products * Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products. * History of malignancies of lymphoid cells and immunodeficiency with lymphoma * Known liver function impairment (ALAT 3 times above upper limit of normal) * Known protein-losing enteropathies or proteinuria. * Known of renal function impairment (creatinine \>120 micromol/L or creatinine \>1.35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs). * Treatment with any investigational medicinal…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in isokinetic muscle strength

Timeframe: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

Changes in maximal oxygen consumption (VO2-max)

Timeframe: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

Trial details

NCT IDNCT02121678

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

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