Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure (PEAK-HF)
The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure
The objective of this study is to compare the effect of monitored, home-based exercise versus hospital-based exercise on the quality of life of patients with congestive heart failure. Secondary objectives are to assess the effect of the intervention on exercise capacity and caregiver burden.
The investigators hypothesize that the exercise training in the home-based environment will be superior to hospital based exercise training.
調査の概要
状態
条件
詳細な説明
Congestive heart failure (CHF) is a chronic disease that is associated with enormous burden of illness. Patients with CHF have diminished health-related quality of life, and due to the high demand associated with their everyday activities and self-management, there is consequently a burden upon family caregivers. Though exercise is a component of clinical practice guidelines for the management of CHF, previous studies have not examined the interrelationships among changes in exercise capacity, health-related quality of life (HRQL) and important predictor variables such as self-efficacy, as a result of exercise training in CHF patients. Furthermore, research to date has failed to examine whether a hospital-based or a home-based approach to exercise is the best-suited strategy for long-term adoption and benefit from exercise training. Thus, the most important effective approach to, and environment for, exercise training to improve the health and self-management of CHF patients has not yet been determined. This study will address some important gaps in the existing literature related to the benefits of exercise in CHF, specifically how different exercise approaches and strategies contribute to an individual's HRQL and self-efficacy.
This is a prospective, randomized controlled trial using a two-group, repeated measures design. Male and female patients with New York Heart Association (NYHA) Functional Class I-III CHF will be eligible to participate. Participants will be randomized to receive either supervised, hospital-based exercise or monitored home-based exercise. The participants in the study will train for a period of six months and will be reassessed six months following completion of the intervention to assess sustainability of any observed changes.
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
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-
Ontario
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Hamilton、Ontario、カナダ、L8L 2X2
- Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
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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:
- chronic stable heart failure
- NYHA class I, II or III
- willing and able to regularly attend a supervised exercise program
- provision of written, informed consent
Exclusion Criteria:
- unstable angina in the last month
- recent acute MI (last 3 months) which precipitated heart failure
- hospitalized for heart failure in past month
- severe chronic pulmonary disease (FEV1 <40%)
- uncontrolled hypertension (B/P >140/90)
- orthopedic, neurological or psychiatric illness precluding participation in exercise
- heart failure that is amenable to revascularization, which is planned in the near future
- NYHA class IV
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：home based exercise training
|
Participants in the home-based group will be advised to exercise, a minimum of 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Prescriptions will include the same elements of those for the hospital group:
Home-based participants will be asked to record their exercise in an exercise log book and will receive bi-weekly telephone calls from exercise personnel to monitor progress, assess and document adherence, revise the exercise prescription if necessary and provide support and education. Patient safety will be monitored during each call and serious health concerns will be relayed, with the patient's permission, to their primary health provider. Patients in this group will be encouraged to call the exercise specialist or kinesiologist with concerns or questions throughout the study. |
|
アクティブコンパレータ：supervised exercise training
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Patients in the hospital-based group will participate in supervised, on-site, group exercise sessions 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Trained exercise personnel (kinesiologists and exercise specialists) will supervise these sessions. Exercise sessions will include:
Exercise will be tracked by the participant in exercise log books. |
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 health-related quality of life (HRQL): Generic and disease specific
時間枠：baseline, 3 months, 6 months, one year
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The Medical Outcomes Short Form-36 will be used to measure generic HRQL. The Minnesota Living with Heart Failure (MLQHF) Questionnaire will be used to measure disease specific HRQL. |
baseline, 3 months, 6 months, one year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in exercise capacity (peak exercise oxygen uptake - VO2)
時間枠：baseline, 3 months, 6 months, one year
|
PEAK VO2 will be measured while performing a symptom-limited cycle erometry exercise test.
|
baseline, 3 months, 6 months, one year
|
|
Change in self-efficacy for exercise
時間枠：baseline, 3 months, 6 months, one year
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Self-efficacy for exercise will be measured using a self-efficacy for exercise scale developed for clinicial use among cardiac patients (Ewart & Taylor, 1985)
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baseline, 3 months, 6 months, one year
|
|
Change in caregiver burden
時間枠：baseline, 3 months, 6 months, one year
|
The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.
|
baseline, 3 months, 6 months, one year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Heather M Arthur, PhD、Hamilton Health Sciences Corporation
- スタディチェア：Robert S McKelvie, MD, PhD、Hamilton Health Sciences Corporation
- スタディチェア：Jennifer Kodis, MA、Hamilton Health Scienes
- スタディチェア：Kevin Thorpe, MSc、University of Toronto
- スタディチェア：Catherine Demers, MD, MSc、Hamilton Health Sciences Corporation
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
本研究に関する用語
その他の研究ID番号
- NA 5147
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。