Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease (PAD)
2021年12月20日 更新者：Elizabeth Anne Jackson、University of Alabama at Birmingham
Peripheral arterial disease (PAD) is a significant vascular condition affecting millions of adults.
Exercise such as walking is highly effective for reducing PAD symptoms such as claudication (pain with walking) and improving physical function.
The trial examines the efficacy of a internet-delivered walking program for patients with PAD.
Comparator groups including telephone counselling, the combination of internet-delivered walking program + telephone counseling, or usual care.
The primary outcome of interest is maximal walking distance.
調査の概要
詳細な説明
With the aging of the American population, the numbers of adults with peripheral arterial disease (PAD) will increase significantly over the next several decades.
Patients with PAD are at increased risk for morbidity and mortality including both cardiovascular and all-cause mortality.
While regular physical activity reduces risk for vascular events and is recommended for treatment of PAD patients, few patients meet recommended goals.
Exercise programs which increase long-term adherence to walking can be an important contribution to PAD treatment.
Our Internet-based intervention, builds on a walking enhancement program developed by members of our team and is shown to improve adherence among patients with vascular disease such as coronary artery disease (CAD).
Using a randomized, controlled trial study design, we propose to test an automated Internet-based walking program to improve long-term adherence to walking while increasing walking distance, and health-related quality of life, among patients with PAD.
Participants will be randomized to 1 of four study groups: 1) weekly telephone counseling, 2) an Internet-based walking program, 3) a combination of telephone counseling and Internet-based walking program, or 4) a usual care group.
The Internet-based walking program has been shown to increase both adherence to walking and overall walking duration in populations with chronic complex conditions such as CAD and diabetes.
There is a strong need to develop interventions, easily generalizable to a real-world population, to improve the reach of lifestyle interventions which result in improved physical function and adherence to regular exercise among complex medical patients.
Patients such as those with PAD (a CAD risk equivalent) stand to benefit the most from such programs.
研究の種類
介入
入学 (実際)
172
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama Birmingham
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Michigan
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Ann Arbor、Michigan、アメリカ、48106
- University of Michigan
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Age ≥ 40
Diagnosis of PAD due to atherosclerosis, documented by 1 or more of the following:
- documented ankle brachial index (ABI) ≤ 0.9 in at least one leg
- toe brachial index ≤ .70 for participants with an ABI > 1.3
- documented arterial disease by MRI, CT or angiogram Ability to walk at least 150 feet without the assistance of a cane or walker. Are sedentary (defined as < 150 minutes per week of physical activity). Able to obtain medical clearance from a primary care provider, cardiologist, vascular specialist, endocrinologist, nurse practitioner, or physician assistant.
Competent to give informed consent. Have regular access to a computer with an Internet connection that allows software downloading.
Be a regular email user (check email at least once a week).
Exclusion Criteria:
PAD due to non-atherosclerotic causes such as trauma, entrapment syndromes or congenital anomalies.
No primary provider, or cardiologist or vascular provider Life expectancy of under 1-year Co-morbidities which limit physical activity to a severe degree (defined as the inability to walk a grocery store aisle unassisted) Signs of critical limb ischemia and/or planned peripheral revascularization in the next 12-months
A diagnoses of any of the following cardiovascular events in the past 3 months:
- stroke/transient ischemic attack
- myocardial infarction
- unstable angina
- percutaneous coronary intervention
- coronary bypass graft surgery A diagnoses of any of the following cardiovascular conditions
- severe valve disease untreated
- complex arrhythmia untreated
- New York Heart Association class III-IV heart failure Current substance abuse, or significant psychiatric disorder, or dementia which limits the participant's ability to follow the study protocol Pregnancy Non-English speaking
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：支持療法
- 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 |
|---|---|
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アクティブコンパレータ：Telephone Counseling
Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs
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4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
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実験的：Internet-based walking program
Weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.
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Four-month Internet-based walking program consisting of weekly step count goals
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実験的：Telephone counseling and Internet-based walking program
Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs plus weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.
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4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
Four-month Internet-based walking program consisting of weekly step count goals
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介入なし：Usual Care
Subjects will continue with their health care as usual
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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 |
|---|---|---|
|
Change in maximal walking distance
時間枠：Baseline to 4 months
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measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
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Baseline to 4 months
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Change in PAD-specific health-related quality of life
時間枠：Baseline to 4 months
|
measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
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Baseline to 4 months
|
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Change in general health-related quality of life
時間枠：Baseline to 4 months
|
measured using the EuroQol 5 Dimension Scale (EQ-5D) which is comprised of a descriptive system questionnaire containing 5 questions and a visual analogue scale ranging from 0 to 100 with 0 being worse health state imaginable and 100 being best health state imaginable.
The descriptive system questionnaire is scored by assigning a 1-digit number to the participant's answer choice for each of the 5 questions, then combining each into a 5-digit number indicating their health state.
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Baseline to 4 months
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Change in global health-related quality of life
時間枠：Baseline to 4 months
|
measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Questionnaire that includes questions from physical, mental, and social health domains and is scored using a T-score metric.
A higher score equals more of a concept being measured which can indicate better or worse outcomes depending on the concept being measured.
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Baseline to 4 months
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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 |
|---|---|---|
|
Change in pain-free walking distance
時間枠：Baseline to 4 months
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measured using the Gardner-Skinner protocol treadmill test, time to onset of claudication
|
Baseline to 4 months
|
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Change in maximal walking distance
時間枠：Baseline to 12 months
|
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
|
Baseline to 12 months
|
|
Change in PAD-specific health-related quality of life
時間枠：Baseline to 12 months
|
measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
|
Baseline to 12 months
|
|
Change in general health-related quality of life
時間枠：Baseline to 12 months
|
measured using EuroQol 5 Dimension Scale (EQ-5D) which is comprised of a descriptive system questionnaire containing 5 questions and a visual analogue scale ranging from 0 to 100 with 0 being worse health state imaginable and 100 being best health state imaginable.
The descriptive system questionnaire is scored by assigning a 1-digit number to the participant's answer choice for each of the 5 questions, then combining each into a 5-digit number indicating their health state.
|
Baseline to 12 months
|
|
Change in global health-related quality of life
時間枠：Baseline to 12 months
|
measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Questionnaire that includes questions from physical, mental, and social health domains and is scored using a T-score metric.
A higher score equals more of a concept being measured which can indicate better or worse outcomes depending on the concept being measured.
|
Baseline to 12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Elizabeth A. Jackson, MD MPH FACC、University of Alabama at Birmingahm
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2014年9月1日
一次修了 (実際)
2021年12月1日
研究の完了 (実際)
2021年12月1日
試験登録日
最初に提出
2013年12月5日
QC基準を満たした最初の提出物
2013年12月20日
最初の投稿 (見積もり)
2013年12月27日
学習記録の更新
投稿された最後の更新 (実際)
2021年12月21日
QC基準を満たした最後の更新が送信されました
2021年12月20日
最終確認日
2021年12月1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。
末梢動脈疾患の臨床試験
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Telephone counselingの臨床試験
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University of PittsburghNational Institute of Nursing Research (NINR); National Institute on Aging (NIA)完了