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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03805061
Other study ID # 128
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2008
Est. completion date November 1, 2008

Study information

Verified date January 2019
Source Okmeydani Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 1, 2008
Est. primary completion date October 30, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Okmeydani Training and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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