Implementing Physical Activity Guidelines for Adults With MS
A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.
The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life.
This randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
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Hamilton、Ontario、カナダ、L8S 4K1
- McMaster University, Physical Activity Centre for Excellence
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Kingston、Ontario、カナダ、K7L 3N6
- Queens University
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-
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:
- Diagnosis of MS with mild-moderate disability (EDSS 1-7)
- Aged 18-60
- Medical clearance to participate in physical activity
Exclusion Criteria:
- current participation in regular physical activity (at least twice-weekly)
- other serious medical condition that might impair ability to participate in strength or aerobic exercise
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Direct Referral to Physical Activity
The REF group will be referred to a centre-based community exercise program in their respective community (either the MacWheelers or Revved Up) by a clinical neurologist where they will be prescribed exercise based on the PAGs for adults with MS, and according to their individual capabilities.
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Participants randomized to the Direct Referral to Physical Activity Arm will be provided with a referral to a physical activity program in their community and will be closely monitored in this program for 16 wks.
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介入なし：Control
The CON group will be provided with a print copy of the PAGs and a link to an online resource for physical activity information.
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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 |
|---|---|---|
|
Adherence to the Physical Activity Guidelines
時間枠：3 years
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Adherence to the physical activity guidelines will be analyzed by having participants fill in a weekly physical activity log that will be sent to them by email.
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3 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical Fitness
時間枠：At baseline and after the 16 week intervention
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Peak oxygen uptake, maximum muscle strength, bodyweight
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At baseline and after the 16 week intervention
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Perceived Quality of Life
時間枠：At baseline and after the 16 week intervention
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Multiple Sclerosis Quality of Life (MSQoL) scale
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At baseline and after the 16 week intervention
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Fatigue
時間枠：At baseline and after the 16 week intervention
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Multiple Sclerosis Fatigue Impact Scale (MSFIS)
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At baseline and after the 16 week intervention
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Mobility
時間枠：At baseline and after the 16 week intervention
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25ft walk test
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At baseline and after the 16 week intervention
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Blood markers of cardiovascular disease risk
時間枠：At baseline and after the 16 week intervention
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blood lipid panel, HbA1c, fasting glucose
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At baseline and after the 16 week intervention
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Audrey L Hicks, Ph.D.、McMaster University
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 (実際)
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 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- MSProject2001
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。