Clinical trial NCT03779724: Isokinetic Exercises in Patients With Multiple Sclerosis
Official title: The Effects of Isokinetic Exercises on Muscle Strength, Joint Position Sense, and Kinesiophobia in Patients With Multiple Sclerosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
isokinetic
exercises
joint position sense
kinesiophobia
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective randomized controlled trial aimed to recruit 50 patients with MS from the physical medicine and rehabilitation clinic of Ankara Training and Research Hospital, Health Sciences University, Ankara, Turkey. Fifty patients who met the inclusion criteria were enrolled in the study. Fifty patients were randomized to two groups: isokinetic exercise (Group 1) (n=25) and home exercise (Group 2) (n=25). Randomization was completed using sequentially numbered, opaque envelopes by the investigator. All patients gave informed consent before the assessment. The outcome measures were assessed initially and at eighth week after the treatment. Group 1 performed isokinetic concentric quadriceps and hamstring strengthening exercises under supervision and Group 2 performed lower extremity muscle strengthening and balance exercises at home.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Isokinetic Muscle Strength Test of the More and Less Affected Knees
timeFrame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
measure: Joint Position Sense of the More and Less Affected Knees
timeFrame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
measure: Tampa Scale of Kinesiophobia
timeFrame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
measure: Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score
timeFrame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
measure: Visual Analog Scale
timeFrame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Training and Researc Hospital, Health Sciences University
Study officials:
affiliation: Aksaray University Training and Research Hospital
name: Melek A Selçuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.