Effects of Aerobic and Isokinetic Exercise in Multiple Sclerosis

NCT03805061 | Completed FDA Device

• 1 other identifier: 128
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; aerobic; isokinetic; exercise

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Aerobic exercise group

ACTIVE COMPARATOR

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'

Isokinetic exercise group

ACTIVE COMPARATOR

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'

Interventions

'aerobic exercise' OTHER

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.

Aerobic exercise group

'isokinetic exercise' DEVICE

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.

Isokinetic exercise group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sevgi Atar, M.D.

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Administrative, Specialist, M.D.

Model Details: 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.

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: January 15, 2019
• Study Start: April 30, 2008
• Primary Completion: October 30, 2008
• Study Completion: November 1, 2008
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share