Sms Guided Training After Acute Stroke (StrokeWalk)
Sms Guided Training After Acute Stroke: A Pilot Study
The purpose of this exploratory study is to investigate how a predetermined outdoor walking program (12 weeks) is best delivered to individuals with stroke over 18 years, either by smartphone and the Short Message Service (SMS) or video link.
Furthermore, the aim is to investigate how the study design works in practice and determine the effects of the outdoor walking exercise program in combination with a leg exercise on physical functioning (walking capacity, gait speed, mobility and grip strength).
調査の概要
詳細な説明
Twenty community-living individuals in Uppsala municipality will be included and treated with a cross-over design. Ten individuals will initially receive exercise instructions to their smartphones via Short Message Service (SMS) for 6 weeks and after that instructions by a video link (6 weeks). Another 10 individuals will initially receive instructions by a video link and then switching to management with SMS after 6 weeks of training.
Intervention: Participants are supposed to perform an outdoor walking exercise program for 12 weeks. The walks should gradually increase in frequency and intensity, and is expected to start after discharge from the stroke department, after the assessment. The first 2 weeks start with daily walks. The walks will be conducted at a pace that increases the heart rate but still makes it possible to talk. The intensity and frequency of walks will progressively increase performed according to the Borg scale: 12-15, ie, moderate to strenuous. Participants will walk 5-7 days/week. Added to this is a strength exercise, which should be performed in connection with the walk training.
Methods: Questionnaires and medical records used for documentation of age, sex, comorbidity, blood pressure, medications and previous education.
Assessment of motor function, cognition, level of physical activity are only performed as screening at baseline measurements. Objective evaluation of the participants' adherence to the outdoor walking program will be measured with a training diary where the individual documents whether they have followed the training instructions.
Power analysis is not performed since this is an exploratory study. The investigators will analyze the data using an intention-to -treat. The investigators will also do a 'per-protocol analysis, where only participants who completed the training are included. Participants should have participated in at least 50% of the training sessions. All analyzes will be done using SPSS version 23 (IBM, Armonk).
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:
- ≥ 18 years
- Verified ischemic cerebral infarction or intracerebral hemorrhage.
- Sufficient walking capacity and motor function
- Able to communicate in Swedish
- Signed consent
Exclusion Criteria:
Are one or more of the following:
- Subarachnoid bleeding
- Insufficient cognition and impaired ability to understand instructions
- Medical problems that make it unsuitable to participate
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:なし
- 介入モデル:単一グループの割り当て
- 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:Training after acute stroke
Intervention: Outdoor walking and strength training.
|
Outdoor walking: Participants will receive daily training instructions via Short message Service (SMS) over 12 weeks.
The walks are increased in frequency and intensity.
The intensity are rated using the Borg scale to 12-15.
The first 2 weeks begins with daily walks of 10 minutes.
The last 4 weeks the walk training will partly be performed in intervals in combination with conventional outdoor walks.
The interval training includes warming-up (5 minutes), fast walking for 4 minutes alternated with slower walking for three minutes.
This is repeated 3 times, followed by cooling down for about five minutes.
Strength training: to repeatedly get up from sitting.
Number of repetitions will increase from 5-20 per set and will be performed daily in 3 sets with a short rest between each set.
|
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 |
|---|---|---|
|
6 Minutes Walk Test
時間枠:change from baseline walking capacity to three months
|
walking capacity
|
change from baseline walking capacity to three months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Short Physical Performance Battery
時間枠:change from baseline mobility to three months
|
mobility
|
change from baseline mobility to three months
|
|
10 meters walk test
時間枠:change from baseline gait speed to three months
|
gait speed
|
change from baseline gait speed to three months
|
|
Montreal Outcome Assessment
時間枠:baseline
|
cognitive function
|
baseline
|
|
Modified Rankin Scale
時間枠:baseline
|
motor function
|
baseline
|
|
Saltin Grimby Physical Activity Level Scale
時間枠:baseline
|
level of physical activity
|
baseline
|
|
Jamar hand dynamometer
時間枠:change from baseline hand-grip strength to three months
|
hand-grip strength
|
change from baseline hand-grip strength to three months
|
|
The Visual Analogue Rating Scale (VAS)
時間枠:change from six baseline to three months.
|
Report of how to deliver the best instructions.
|
change from six baseline to three months.
|
|
The Visual Analogue Rating Scale (VAS)
時間枠:change from baseline to three months.
|
Report of how to deliver the best instructions.
|
change from baseline to three months.
|
協力者と研究者
捜査官
- 主任研究者:Birgit Vahlberg, Med Dr, RPT、VO Paramedicin
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
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。