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

Sponsor
Dokuz Eylul University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05571631
Collaborator
(none)
30
2
25

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effect of the Combination of Arm Ergometer Exercise and Balance Training on Upper Extremity Function in People With Multiple Sclerosis
Anticipated Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Sep 15, 2024
Anticipated Study Completion Date :
Nov 15, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Nine-Hole Peg Test [Change from Baseline at 12 weeks]

    The Nine-Hole Peg Test measures finger dexterity.

Secondary Outcome Measures

  1. Expanded Disability Status Scale [Baseline]

    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.

  2. Jamar Hand Dynamometer [Change from Baseline at 12 weeks]

    The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.

  3. Arm Function in Multiple Sclerosis Questionnaire [Change from Baseline at 12 weeks]

    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.

  4. Preference-based Multiple Sclerosis Index [Change from Baseline at 12 weeks]

    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).

  5. Estimated VO2 Max [Change from Baseline at 12 weeks]

    Estimated VO2max will be calculated Astrand-Rhyming Cycle Ergometer Test.

  6. Modified Fatigue Impact Scale [Change from Baseline at 12 weeks]

    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.

  7. Timed Up and Go test [Change from Baseline at 12 weeks]

    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.

  8. Activities-Specific Balance Confidence Scale [Change from Baseline at 12 weeks]

    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.

  9. Coin Rotation Test [Change from Baseline at 12 weeks]

    The coin Rotation Test is developed to assess fine motor skills and speed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Dokuz Eylul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Serkan Ozakbas, Prof. Dr., Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT05571631
Other Study ID Numbers:
  • 7181-GOA
First Posted:
Oct 7, 2022
Last Update Posted:
Oct 7, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Serkan Ozakbas, Prof. Dr., Dokuz Eylul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2022