Effect of Resistance and Aerobic Exercise in CIDP or MMN

NCT02121678 | Completed

• 1 other identifier: 2013-200
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy; Multifocal Motor Neuropathy

Keywords

Resistance training; Aerobic exercise; Isokinetic muscle strength; Bicycle ergometry test; Subcutaneous immunoglobulin

Outcome Measures

Primary Outcomes (2)

• 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

  -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

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

Secondary Outcomes (5)

• Change in Medical Research Council (MRC)

  -12, 0, 6, 12, 18, 24 weeks

• Change in Overall Disability Sum Score (ODSS)

  -12, 0, 6, 12, 18, 24 weeks

• Change in 6-Minute Walk test

  -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

  -12, 0, 6, 12, 18, 24 weeks

• Change in Fatigue Severity Score (FSS)

  -12, 0, 6, 12, 18, 24 weeks

Study Arms (2)

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

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

Other: Resistance training; Other: Aerobic training

Interventions

Resistance training OTHER

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)

Run-in - Aerobic - Resistance; Run-in - Resistance - Aerobic

Aerobic training OTHER

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.

Run-in - Aerobic - Resistance; Run-in - Resistance - Aerobic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Department of Neurology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Department of Neurology, Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: April 23, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2015-08

Locations

DK (2)