Effects of Vestibular Rehabilitation on MS-related Fatigue: a Randomized Control Trial
The Effects of Vestibular Rehabilitation on MS-related Fatigue and Upright Postural Control: a Randomized Controlled Trial
調査の概要
詳細な説明
The investigators investigated the effect of a vestibular exercise program designed to help people with MS with two common problems: fatigue and difficulties with balance while standing and walking. Our primary aim was to compare the results from persons with MS that participated in the vestibular exercises (Experimental group) to individuals who participated in a more typical rehabilitation exercise program consisting of stretching and endurance exercise (Exercise Control group) or people who did not receive exercise treatment (Control group).
The study was a 14-week randomized controlled trial. Thirty eighty participants were followed for four weeks before being randomly assigned to one of the three groups. Each participant had an equal chance of being assigned to either the Experimental group, Exercise Control group or the Control group. The Experimental group received a standardized vestibular exercise program that included upright postural control (balance) and eye movement exercises (6 one-hour sessions over 6 weeks). The Exercise Control group received endurance training using a stationary bicycle and leg stretching exercises (6 one-hour sessions over 6 weeks). Both exercise groups received the same 5 minutes of fatigue management education. Measurements of self-reported fatigue, dizziness and depression, and performance of a computerized, standing upright postural control test and walking capacity test were measured to determine benefits from the interventions. Participants in the Control group did not exercise, however if they chose, received the treatment within the clinical setting upon completion of their participation in the study.
The investigators hypothesized that: 1) participants in the Experimental group would improve significantly in fatigue and balance; 2) improvements found in the Experimental group would be significantly greater than improvements in the Exercise Control group and Control group.
Results: Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week unsupervised follow-up.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- (1) Clinically definite MS confirmed by a board certified Neurologist
- (2) Kurtzke Expanded Disability Status Scale (EDSS) 0.0 to 6.0 (ranges and corresponding ambulatory status: 0.0 to 4.5 fully ambulatory without assistive device; 5.0 to 5.5 impaired ambulatory status without assistive device; 6.0 impaired ambulatory status with intermittent or unilateral constant assistive device)
- (3) Age: 18 to 65 years (65 years has been set as the upper limit of age to decrease the possible age-related changes in physical strength, endurance, and upright postural control)
- (4) Male or Female (MS affects both gender types)
- (5) Comprehension of the general concept of the study and ability to make informed consent (see Section I. Special Consent Issues). (6) Minorities included
- (7) Self-reported fatigue level on the Modified Fatigue Impact Scale (MFIS) of a total score > 45 (This criterion has been used in previous studies investigating treatment for MS-related fatigue utilizing the MFIS)
- (8) Sensory organization test (SOT) composite score of < 72
Exclusion Criteria:
- (1) Non-ambulatory
- (2) Utilization of agents to control fatigue: i.e. medications: Amantadine, Pemoline, Dexedrine Amphetamine, Methylphenidate, Provigil, Ritalin, Prokarin.
- (3) Utilization of medication(s) that have known possible side effects of fatigue such as: skeletal muscle relaxants (i.e. Baclofen, Zanaflex), Statin Drugs, pain medication (i.e. Opioids, tricyclic antidepressants (TCAs), anti-epileptic drugs (AEDs)
- (4) Any other possible cause of fatigue: major sleep disorder, clinically diagnosed major depressive disorder, anemia, hypothyroidism, B12 deficiency, cancer
- (5) Other neurological disorder which might contribute to significant balance problems, including cerebral vascular accident, peripheral neuropathy (separate from MS diagnosis, such as diabetes mellitus), peripheral vestibular disorders (unilateral/bilateral vestibular hypofunction: benign positional paroxysmal vertigo, Meniere's disease, acoustic neuroma)
- (6) Change in MS specific medication (for disease modification) in the last three months
- (7) Documented MS-related exacerbation in the last six months
- (8) Any medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise testing and/or result in limitations for participation in an active exercise program or aerobic exercise program, as recommended by the American College of Sports Medicine (ACSM)
- (9) Participation in an exercise routine specifically designed as a vestibular and/or aerobic exercise program within eight weeks prior to study participation.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Exercise: Vestibular Rehabilitation
Balance and eye movement training
|
Balance and eye movement training
|
|
アクティブコンパレータ：Exercise Control
Bicycle ergometry and stretching
|
Bicycle ergometry and stretching
|
|
介入なし：Wait-listed Control
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-reported fatigue
時間枠：10 weeks
|
Modified Fatigue Impact Scale.
Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week unsupervised follow-up.
|
10 weeks
|
|
Upright postural control
時間枠：10 weeks
|
Sensory Organization Test (SOT)-Posturography.
Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week unsupervised follow-up.
|
10 weeks
|
|
Walking capacity
時間枠：10 weeks
|
6-minute walk test (6MWT).
Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week unsupervised follow-up.
|
10 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-reported dizziness
時間枠：10 weeks
|
Dizziness Handicap Inventory.
Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week unsupervised follow-up.
|
10 weeks
|
|
Self-reported depression
時間枠：10 weeks
|
Beck Depression Inventory - II.
Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week unsupervised follow-up.
|
10 weeks
|
協力者と研究者
捜査官
- 主任研究者：Margaret Schenkman, PT, PhD、University of Colorado, Denver
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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