Multiple Sclerosis Clinical Trial
Official title:
Exercise in Persons With Multiple Sclerosis
NCT number | NCT04944251 |
Other study ID # | 19-4T/43 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | January 19, 2020 |
Verified date | June 2021 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
ABSTRACT Objective: The investigators aimed to determine the effect of regular exercise on aerobic capacity, strength values, and plasma levels of nerve growth factor (NGF) and Neurotrophin-3 (NT-3) in patients with multiple sclerosis (MS), and investigate its effects on MS symptoms including cognitive impairment, fatigue, balance disorders and quality of life. Methods: Forty-three relapsing-remitting MS (RRMS) patients with an EDSS score of 4 or less participated in the study. Participants were divided into 3 groups as aerobic exercise, strength exercise and control groups. The patients in the exercise groups had exercise programs 3 days a week, for 3 months. Aerobic capacity (maximum VO2 value), strength measurements and balance tests were done, and NGF and NT-3 plasma levels were analyzed in all participants at the beginning and end of the study. MSQoL54 quality of life, fatigue impact scale (FIS), Pittsburgh Sleep Quality Index (PSQI) and BICAMS scale were applied to evaluate cognitive functions.
Status | Completed |
Enrollment | 43 |
Est. completion date | January 19, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - A total of 53 relapsing remitting form MS (RRMS) patients between the ages of 18-55 years, diagnosed with definite MS according to 2017 McDonald criteria, and followed up in Ege University MS and Demyelinating Diseases Unit, without an MS attack in the last 3 months, had an EDSS score = 4 that did not change with symptomatic or immunomodulatory treatments within 6 months were included in this prospective randomized controlled study. Exclusion Criteria: - Patients who did not meet the inclusion criteria were excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University | Izmir | Bornova |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aerobic capacity assessment after exercise intervention | Measurement of Aerobic Capacity: Milliliters were used for the amount of oxygen used, kilograms were used for body weight, and minutes were used for time. the amount of oxygen consumed, weight and time will be combined to report aerobic capacity in ml/kg/min.
The unit of aerobic capacity, ml/kg/min, refers to the amount of oxygen the body consumes per kilogram per minute. The indirect Astrand test bicycle test protocol with Lode Corival bicycle ergometer was applied to all patients. The pedal resistance applied in the test and the mean pulse rate were marked in the Astrand normogram, and the aerobic capacities of the patients were calculated. It was observed that aerobic capacity (ml/kg/min) increased in exercise groups after regular exercise. |
Each participant's progress will be tested at the beginning and end of the 12-week training period. | |
Primary | Strength assessment after exercise intervention | Strength Measurements: The kilogram-force (kg-f) is a non-standard Gravitational Metric unit of force. The kilogram-force is equal to the magnitude of the force exerted on one kilogram of mass in a 9.80665 m/s2 gravitational field. Kilogram was used for weight. The force is any influence that, when unopposed, will change the motion of an object. Weight and force will be combined to report strength in kg-f. Strength was examined with an isometric hand and backleg dynamometer in all patients. Strength was examined with an isometric hand and backleg dynamometer in all patients. Two measurements were made, at the beginning and at the end of the study. It was observed that strength values increased in exercise groups after regular exercise. | Each participant's progress will be tested at the beginning and end of the 12-week training period. | |
Primary | plasma neurotrophin values (pg/ml) | Plasma NGF and NT-3 levels were measured with an ELISA kit. Plasma neurotrophin values increased in exercise groups. | Each participant's progress will be tested at the beginning and end of the 12-week training period. |
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