Effect of Arm Ergometer Exercise Training on Upper Extremity Function in People With Multiple Sclerosis.

Investigation of the Effect of the Combination of Arm Ergometer Exercise and Balance Training on Upper Extremity Function in People With Multiple Sclerosis

This study will investigate the effects of a 12-week arm ergometer exercise and balance training on upper extremity function in persons with multiple sclerosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: exercise

Detailed Description

Multiple sclerosis (MS) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system of unknown etiology. The most common clinical signs and symptoms are motor dysfunction, fatigue, spasticity, impaired mobility, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. 66% of people with MS (pwMS) have impaired upper extremity function.

As a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. As a result of this influence, there is a decrease in the functional independence of pwMS, quality of life and participation in activities in the community.

Another common symptom that reduces quality of life, independence, and participation in pwMS is balance disorder, seen in 75% of cases. Abnormality in balance control occurs due to lack of postural stability, limitation of stability limits, slowness to return to the starting position during bending and reaching activities. During interaction with the environment in daily life, proprioceptive inputs from the extremities and subsequent proper trunk control enable the person to keep the center of gravity on the support surface at rest and in activity. In this way, proximal stability is provided and tasks that require participation in daily life with distal mobility are performed. It is necessary to manage these progressive symptoms associated with the disease in order to increase the quality of life of pwMS, increase the rate of participation in society and maintain this increase.

Exercise training represents an existing behavioral treatment approach to safely manage many functional, symptomatic and quality-of-life outcomes in MS. Current literature reports that aerobic exercise has a positive effect on important parameters such as balance, fatigue, walking, quality of life, and pain in pwMS. At the same time, aerobic exercise training with arm ergometry allows pwMS to improve their upper extremity function. Apart from these, the literature has separately examined the effects of exercise training on upper extremity function and balance in pwMS, and positive effects have been shared separately. However, the relationship between these two important issues and the effect of exercise training on this relationship have not been examined.

The aim of the study is to examine the effects of exercise training on upper extremity function and balance in pwMS.

Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 30 participants will randomly be divided into 2 groups as arm ergometer-balance training group and arm ergometer training group. Both exercise training will be given by a physiotherapist, supervised 2 days a week for 12 weeks. Assessments will done at baseline and after 12weeks (post-treatment). Assessments will be done by assessors who are blinded to the group allocation.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serkan Ozakbas, MD; Phone Number: +90 232 412 4964; Email: serkan.ozakbas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A relapsing-remitting or secondary progressive type of multiple sclerosis,
• To be willing to participate in the study.

Exclusion Criteria:

• Another neurological disorder,
• Orthopedic surgery history including the elbow, wrist, shoulder, ankle-foot, knee, hip or spine, affecting balance and upper extremity functions,
• Diagnosed severe cognitive and/or psychiatric impairment,
• Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD
• Having cardiac disease such as hypertension that would be a contraindication to exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm ergometer-balance training; Combination of arm ergometer exercise and balance training	Other: exercise; Arm ergometer will aplied as an aerobic exercise. Combination of balance training and arm ergometer exerise program will applied.
EXPERIMENTAL: arm ergometer; Only arm ergometer exercise training	Other: exercise; Arm ergometer will aplied as an aerobic exercise. Combination of balance training and arm ergometer exerise program will applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine-Hole Peg Test	The Nine-Hole Peg Test measures finger dexterity.	Change from Baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expanded Disability Status Scale	Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.	Baseline
Estimated VO2 Max	Estimated VO2max will be calculated Astrand-Rhyming Cycle Ergometer Test.	Change from Baseline at 12 weeks
Jamar Hand Dynamometer	The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.	Change from Baseline at 12 weeks
Arm Function in Multiple Sclerosis Questionnaire	Arm Function in Multiple Sclerosis Questionnaire is a unidimensional 31-item questionnaire for measuring arm function in MS. The total sum score ranged from 31 to 186 and a high score indicates a low degree of arm function.	Change from Baseline at 12 weeks
Preference-based Multiple Sclerosis Index	The Preference-based Multiple Sclerosis Index is a brief patient-reported outcome measure of health-related quality of life that consists of 5 items: walking, fatigue, mood, concentration, and roles and responsibilities. The scoring algorithm ranges from 0 (dead) to 1 (perfect health).	Change from Baseline at 12 weeks
Modified Fatigue Impact Scale	The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. A higher score indicates higher level of fatigue.	Change from Baseline at 12 weeks
Timed Up and Go test	The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. The time is calculated from the initiation of the instruction to start and ends when the patient has sit down. Higher time represents more static and dynamic balance and mobility impairment.	Change from Baseline at 12 weeks
Activities-Specific Balance Confidence Scale	The Activities-Specific Balance Confidence Scale is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. 16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100. Score of zero represents no confidence, a score of 100 represents complete confidence. Overall score is calculated by adding item scores and then dividing by the total number of items.	Change from Baseline at 12 weeks
Coin Rotation Test	The coin Rotation Test is developed to assess fine motor skills and speed.	Change from Baseline at 12 weeks

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 15, 2022
• Primary Completion (ANTICIPATED): September 15, 2024
• Study Completion (ANTICIPATED): November 15, 2024

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (ACTUAL): October 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; multiple sclerosis; balance; upper extremity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 7181-GOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No