Chronic Inflammatory Demyelinating PolyneuropathyNCT02121678
Effect of Resistance and Aerobic Exercise in CIDP or MMN
A study testing Resistance training and Aerobic training in people with Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy, Multifocal Motor Neuropathy
- What is being tested?
- Resistance training and Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesDenmark
- Study dates
- Apr 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 product within 3 months prior to first infusion of Gammanorm
- Known or suspected HIV, Hepatitis Virus C or B infection
- Pregnant or nursing women
- Planned pregnancy during course of the study
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Neurology, Aarhus University Hospital
Aarhus C, 8000
Department of Neurology, Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100
About this study
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) or Multifocal Motor Neuropathy (MMN)
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.
- Being tested
- Resistance training, Aerobic training
- Keywords
- Resistance training, Aerobic exercise, Isokinetic muscle strength, Bicycle ergometry test, Subcutaneous immunoglobulin
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Participants do resistance training of selected muscle groups. Resistance are predefined from 1-repetition max (1-RM) and increased during the 12 weeks of training:
- Week 0-4: 70-80 % of 1-RM
- Week 5-8: 75-86 % of 1-RM
- Week 9-12: 80-92% of 1-RM
Participants trains unilateral, the opposite site serves as reference.
- MMN patients train elbow (flexion/extension) and wrist (flexion/extension)
- CIDP patients train knee (flexion/extension) and elbow (flexion/extension)
Aerobic trainingOther
Participants train on ergometer bicycle 2 times weekly increasing during the first weeks to 3 times weekly. Workload is measured before initiation and VO2-max, heart rate and blood pressure will be measured as well.
Patients train with 60-75 % of VO2-max for 30 minutes per training session. They use heart rate monitor to store data.
| Study group | Role | What they receive |
|---|---|---|
| Run-in - Aerobic - Resistance | Experimental | * Week -12 to 0: Run-in period with no training
* Week 0 to 12: Aerobic training on ergometer bicycle
* Week 12 to 24: Resistance training with dumbbells Receives: Other: Resistance training; Other: Aerobic training |
| Run-in - Resistance - Aerobic | Experimental | * Week -12 to 0: Run-in period with no training
* Week 0 to 12: Resistance training with dumbbells
* Week 12 to 24: Aerobic training on ergometer bicycle Receives: Other: Resistance training; Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in isokinetic muscle strength
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
Measured: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
Changes in maximal oxygen consumption (VO2-max)
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
Measured: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
Secondary outcomes (5)
Change in Medical Research Council (MRC)
Measured: -12, 0, 6, 12, 18, 24 weeks
Change in Overall Disability Sum Score (ODSS)
Measured: -12, 0, 6, 12, 18, 24 weeks
Change in 6-Minute Walk test
Measured: -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
Measured: -12, 0, 6, 12, 18, 24 weeks
Change in Fatigue Severity Score (FSS)
Measured: -12, 0, 6, 12, 18, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121678
- Sponsor's protocol ID
- 2013-200
- Status last verified
- Aug 2015
- First submitted
- 17 Feb 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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) or Multifocal Motor Neuropathy (MMN)
- ClinicalTrials.gov ID
- NCT02121678
- Acronym / sponsor ID
- 2013-200
- Keywords
- Resistance training, Aerobic exercise, Isokinetic muscle strength, Bicycle ergometry test, Subcutaneous immunoglobulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Run-in - Aerobic - Resistance | Experimental | Other: Resistance training, Other: Aerobic training* Week -12 to 0: Run-in period with no training * Week 0 to 12: Aerobic training on ergometer bicycle * Week 12 to 24: Resistance training with dumbbells |
| Run-in - Resistance - Aerobic | Experimental | Other: Resistance training, Other: Aerobic training* Week -12 to 0: Run-in period with no training * Week 0 to 12: Resistance training with dumbbells * Week 12 to 24: Aerobic training on ergometer bicycle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingParticipants do resistance training of selected muscle groups. Resistance are predefined from 1-repetition max (1-RM) and increased during the 12 weeks of training: * Week 0-4: 70-80 % of 1-RM * Week 5-8: 75-86 % of 1-RM * Week 9-12: 80-92% of 1-RM Participants trains unilateral, the opposite site serves as reference. * MMN patients train elbow (flexion/extension) and wrist (flexion/extension) * CIDP patients train knee (flexion/extension) and elbow (flexion/extension) | Other | Run-in - Aerobic - Resistance, Run-in - Resistance - Aerobic |
| Aerobic trainingParticipants train on ergometer bicycle 2 times weekly increasing during the first weeks to 3 times weekly. Workload is measured before initiation and VO2-max, heart rate and blood pressure will be measured as well. Patients train with 60-75 % of VO2-max for 30 minutes per training session. They use heart rate monitor to store data. | Other | Run-in - Aerobic - Resistance, Run-in - Resistance - Aerobic |
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training and Aerobic training in people with Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in isokinetic muscle strength (time frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.