Isokinetic Exercises in Patients With Multiple Sclerosis

NCT03779724 | Completed Results

• 1 other identifier: 5070
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; isokinetic; exercises; joint position sense; kinesiophobia

Outcome Measures

Primary Outcomes (5)

• Isokinetic Muscle Strength Test of the More and Less Affected Knees

  The peak torque/body mass index of the quadriceps and hamstring muscles at 60°/s and 180°/s velocities were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) in Newton/meter. A definite muscle strength value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate better muscle strength.

  At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

• Joint Position Sense of the More and Less Affected Knees

  Absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of the more and less affected knees were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) with active-active angular reproduction method. Estimating the target angel procedure was repeated at 45°, 15°, and 60° and for both the more and less affected legs. After the joint position sense testing, three angles estimated by the patients were averaged, and the angular error was calculated for each target angle. Absolute angular error was calculated by averaging the angular errors, regardless of the numbers being negative or positive. The absolute angular error values of the three target angles were averaged to obtain the mean absolute angular errors. A definite angular error value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate worser joint position sense.

  At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

• Tampa Scale of Kinesiophobia

  Kinesiophobia which is described as fear of movement and physical activity was evaluated using the Tampa Scale of Kinesiophobia, which is a 17-item self-report survey. The range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia. If the total score was above 37 points, the patient was considered to have a high level of kinesiophobia.

  At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

• Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score

  This is a multidimensional health-related quality of life measure that combines both generic and multiple sclerosis-specific symptoms in a single instrument. The 54 items are divided into 12 multi-item and 2 single-item scales.Health distress, overall quality of life, emotional well-being, role limitations-emotional and cognitive funtion items' final scores averaged and mental composite score was calculated. Physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress items' final scores were averaged and physical composite score was obtained.Total score was obtained by averaging the mental and physical composite scores.Final scores can be between 0-100 points for total, mental, physical and pain scores. Higher values indicate better quality of life for total, physical and mental scores and worser pain levels for pain score.

  At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

• Visual Analog Scale

  Pain intensity was evaluated with the Visual Analog Scale. Using a ruler, a 10 cm line was drawn which provided a range of scores from 0-100. Than the patients marked the point that showed their pain intensity on this line. A higher score in Visual Analog Scale indicates greater pain intensity.

  At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

Study Arms (2)

isokinetic exercise

EXPERIMENTAL

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.

Other: exercises

home exercise

ACTIVE COMPARATOR

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.

Other: exercises

Interventions

exercises OTHER

home exercise; isokinetic exercise

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aksaray University Training and Research Hospital: lead

Study Sites (2)

Aksaray University Training and Research Hospital

Aksaray, Turkey (Türkiye)

Location

Ankara Training and Researc Hospital, Health Sciences University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 21493176 BACKGROUND

• 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.

  PMID: 15664681 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Kinesiophobia

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; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The limitations of the study include the low number of patients, lower EDSS scores, lack of a long-term evaluation of isokinetic exercises, and absence of a healthy control group.

Results Point of Contact

• Title: The principal investigator
• Organization: Aksaray University Training and Research Hospital

mlk.aykut@gmail.com

905555289493

Study Officials

• Melek A Selçuk, MD

  Aksaray University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 19, 2018
• Study Start: July 29, 2015
• Primary Completion: July 29, 2016
• Study Completion: July 29, 2016
• Last Updated: July 24, 2019
• Results First Posted: July 24, 2019

Record last verified: 2019-07

Locations

TU (2)