Isokinetic Exercises in Patients With Multiple Sclerosis

NCT ID: NCT03779724

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-29
• Study Completion Date: 2016-07-29

Brief Summary

The investigators evaluated the effects of isokinetic muscle strengthening exercises of the quadriceps and hamstring on muscle strength, joint position sense, pain, kinesiophobia and quality of life in patients with multiple sclerosis.

Detailed Description

Objective: To evaluate the effects of isokinetic exercises on muscle strength, knee joint position sense, pain, kinesiophobia, and quality of life in patients with multiple sclerosis.

Design: Randomized controlled trial. Setting: Outpatient clinic. Participants: Fifty patients with multiple sclerosis. Interventions: Fifty patients who met the inclusion criteria were randomized to an isokinetic exercise (n:25) or home exercise programme (n:25). Sequentially numbered opaque envelopes were used for randomization.

Outcome measures: The outcome measures were the peak torque/body mass index of quadriceps and hamstring muscles at 60°/s and 180°/s velocities, the hamstring/quadriceps ratios at the same velocities, absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of joint position sense of the less and more affected knees, and the scores of Multiple Sclerosis Quality of Life-54, Visual Analogue Scale, and Tampa Scale of Kinesiophobia.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

isokinetic exercise

The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.

Group Type: EXPERIMENTAL

exercises

Intervention Type: OTHER

home exercise

The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.

Group Type: ACTIVE_COMPARATOR

exercises

Intervention Type: OTHER

Interventions

exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• definite relapsing remitting MS and secondary progressive MS diagnosis
• mild and moderate MS determined by Kurtzke Expanded Disability Status Scale (EDSS) scores below 6.5
• a disease duration of more than one year.

Exclusion Criteria

• having an acute exacerbation within the last three months
• intravenous pulse steroid therapy in the last four weeks
• grade 3-4 spasticity according to the Modified Ashworth Scale
• severe vision impairment
• severe fatigue and depression
• past knee surgery
• other neurologic diseases
• systemic diseases
• pregnancy
• having received an exercise program within the last four weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aksaray University Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Melek Aykut Selçuk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melek A Selçuk, MD

Role: PRINCIPAL_INVESTIGATOR

Aksaray University Training and Research Hospital

Locations

Aksaray University Training and Research Hospital

Aksaray, , Turkey (Türkiye)

Ankara Training and Researc Hospital, Health Sciences University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Yahia A, Ghroubi S, Mhiri C, Elleuch MH. Relationship between muscular strength, gait and postural parameters in multiple sclerosis. Ann Phys Rehabil Med. 2011 May;54(3):144-55. doi: 10.1016/j.rehab.2011.02.004. Epub 2011 Mar 9. English, French.

Reference Type: BACKGROUND

PMID: 21493176 (View on PubMed)

Robineau S, Nicolas B, Gallien P, Petrilli S, Durufle A, Edan G, Rochcongar P. [Eccentric isokinetic strengthening in hamstrings of patients with multiple sclerosis]. Ann Readapt Med Phys. 2005 Feb;48(1):29-33. doi: 10.1016/j.annrmp.2004.04.005. French.

Reference Type: BACKGROUND

PMID: 15664681 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5070

Identifier Type: -

Identifier Source: org_study_id