Clinical trial NCT05571631: Effect of Arm Ergometer Exercise Training on Upper Extremity Function in People With Multiple Sclerosis.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
upper extremity
balance
rehabilitation
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nine-Hole Peg Test
timeFrame: Change from Baseline at 12 weeks
Secondary outcomes:
measure: Expanded Disability Status Scale
timeFrame: Baseline
measure: Jamar Hand Dynamometer
timeFrame: Change from Baseline at 12 weeks
measure: Arm Function in Multiple Sclerosis Questionnaire
timeFrame: Change from Baseline at 12 weeks
measure: Preference-based Multiple Sclerosis Index
timeFrame: Change from Baseline at 12 weeks
measure: Estimated VO2 Max
timeFrame: Change from Baseline at 12 weeks
measure: Modified Fatigue Impact Scale
timeFrame: Change from Baseline at 12 weeks
measure: Timed Up and Go test
timeFrame: Change from Baseline at 12 weeks
measure: Activities-Specific Balance Confidence Scale
timeFrame: Change from Baseline at 12 weeks
measure: Coin Rotation Test
timeFrame: Change from Baseline at 12 weeks
Other outcomes:
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