Effects of Aerobic and Isokinetic Exercise in Multiple Sclerosis

Evaluation of the Effects of Aerobic and Isokinetic Exercise Program on Muscle Power Cardiovascular System and Life Quality in Multiple Sclerosis Patients

The investigators aimed in this study to measure the muscular strength, cardiovascular system and quality of life effects of rehabilitation with aerobic and isokinetic exercise program in MS patients.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: 'aerobic exercise'; Device: 'isokinetic exercise'

Detailed Description

A total of 40 patients enrolled in the study from outpatient clinics were included. Two groups were formed, namely 'aerobic exercise' and 'isokinetic exercise' groups. Using modified Bruce protocol, effort capacities were measured with Humac Norm Cybex dynamometer, 6 min. walking distance and MSQOL-54 scale were used to assess the quality of life. The aerobic exercise group by using treadmill their walking speeds were adjusted according to the maximum speed at which the person could walk was performed for a period of ; 8 weeks, 3 days a week, 30-45 minutes each patient according to the progressive exercise method. 5-10 minutes warm-up exercise was performed before starting to work, 5-10 minutes stretching exercise at the end of the exercise. Patients in the isokinetic exercise group pedaled a bicycle ergometer for warming with low resistance for 5 minutes before starting to exercise, and exercise was applied for 5-10 minutes to cool down at the end of the study. The exercise program was applied for 8 weeks with 3 repetitions per week.

Assessment of exercise capacity (effort capacity) was performed by applying the Norav Trackmaster TMX 425 Treadmill Exercise Device by applying Modified Bruce protocol. Patients' total exercise times were expressed in seconds. Indirect maximum amount of oxygen volume (VO2 max) values were calculated using heart rate obtained with submaximal treadmill exercise.All the cases participating in the study were compared in terms of the pre-treatment MSQoL-54 scale and the MSQoL-54 scale subscale.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Multipl Sclerosis
• 18-65 years old adults
• Patients signed informed consent forms

Exclusion Criteria:

• Non-MS musculoskeletal system diseases
• Congenital anomalies, limb amputations
• Accompanying neurological diseases (Parkinson, Alzheimer, Polyneuropathy etc.)
• Vestibular system diseases
• Chronic diseases (diabetes mellitus, chronic obstructive pulmonary disease, hypertension, hyperlipidemia, severe cardiac disease, malignancy)
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic exercise group; Group 1 was 'aerobic exercise group'. Patients in this group were included in an aerobic exercise rehabilitation program that they would apply for 3 days per week for 8 weeks. The aerobic exercise group by using treadmill their walking speeds were adjusted according to the maximum speed at which the person could walk was performed for a period of ; 8 weeks, 3 days a week, 30-45 minutes each patient according to the progressive exercise method. 5-10 minutes warm-up exercise was performed before starting to work, 5-10 minutes stretching exercise at the end of the exercise.	Other: 'aerobic exercise'; The aerobic exercise group by using treadmill their walking speeds were adjusted according to the maximum speed at which the person could walk was performed a period of; 8 weeks, 3 days a week, 30-45 minutes each patient.
Active Comparator: Isokinetic exercise group; Group 2 was 'isokinetic exercise group'. Patients in this group were included in an isokinetic exercise rehabilitation program that they would apply for 3 days per week for 8 weeks. Patients in the isokinetic exercise group pedaled a bicycle ergometer for warming with low resistance for 5 minutes before starting to exercise, and exercise was applied for 5-10 minutes to cool down at the end of the study.	Device: 'isokinetic exercise'; Patients in the isokinetic exercise group pedaled a bicycle ergometer for warming with low exercise and exercise was applied for 5-10 minutes to cool down at the end of the study. were included in a rehabilitation program that they would apply for 3 days per week for 8 weeks.The measuring of isokinetic muscle strength, CSMI Humac Norm isokinetic dynamometer's commonly used angular velocities of 60 ° and 180 ° / sec was used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strenght outcomes	The measuring of muscle strength, CSMI Humac Norm isokinetic dynamometer's commonly used angular velocities of 60 ° and 180 ° / sec was used. The muscle strenght peak torque value was newton-meter (Nm)	8 weeks
Quality of life outcomes	Quality of life was assesment via Multiple Sclerosis Quality of Life-54 instrument (MSQoL-54). MSQol-54 consists of 54 questions in total. In all cases, they were asked to fill in the questionnaire alone and by reading it themselves. The overall MSQoL-54 scale should be between in 0-100 scores. Higher scores better than lower scores.	8 weeks
The effort capacity outcomes	The effort capacity was performed by applying the Norav Trackmaster TMX 425 Treadmill Exercise Device by Applying Modified Bruce Protocol. The values of the effort capacity were assesment as maximum amount of oxygen volume (ml/kg/min.).	8 weeks

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• Investigators: Principal Investigator: Sevgi Atar, M.D., Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2008
• Primary Completion (Actual): October 30, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: January 13, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: exercise; Multiple sclerosis; aerobic; isokinetic
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is any plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes