Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01339234
Eligibility Criteria:
Inclusion Criteria:
* Signed, written informed consent
* Males or non-pregnant females, 18-60 years of age (inclusive)
* Clinically definite PPMS as per the diagnostic criteria of Thompson et al (2000)
* Expanded disability status score 5.0-8.0 (constant assistance required)
* Body weight \<90kg (due to support limitations of treadmill)
* Approval from physician to participate in the exercise program
* Ability to tolerate upright locomotion of the body weight supported treadmill
* Ability to visit the different sites required for the study
* Ability to commit to 3 weekly training sessions for the duration of 24 weeks
Exclusion Criteria:
* Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS
* Any other serious medical condition that might impair the subject's ability to walk on a treadmill and/or participate in aerobic exercise (including but not limited to: documented heart disease or unstable angina, uncontrolled cardiac dysrhythmia, chronic obstructive lung disease, recent non-traumatic fracture, osteoporosis and severe skin ulcerations)
* Female patients who do not agree to use effective contraceptive method(s) during the study
* Current use or use within the last 2 months of any on- or off-label disease-modifying therapy including IFN-β, glatiramer acetate, IV steroids, mitoxantrone, azathioprine, and cyclophosphamide
* Previous experience with supported treadmill training
* Kidney disease, peripheral vascular disease or poor circulation
* Inability to undergo MRI or MRI with gadolinium administration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01339234
Study Brief:
Protocol Section:
NCT01339234