Investigating a Well-being Review in Pulmonary Hypertension
Investigating the Feasibility of a Randomised Controlled Trial of a Physiotherapy Well-being Review in Patients With Pulmonary Hypertension.
Pulmonary Hypertension (PH) is a rare disease that makes patients easily become breathless. There is evidence that people with PH can benefit from exercise; we want to look at how they can access rehabilitation in their local community.
Aim: To see if it is feasible to study physiotherapy well-being reviews in PH. Step 1: We will interview some patients with PH who have had rehabilitation and ask questions about their experiences. We will also ask what they think we should measure to show any difference their rehabilitation has made to them. The findings from Step 1 will help us to shape the details of Step 2, where we will conduct a small study to see if it is feasible to run a full study. Participants will be divided randomly into a treatment group and a control group. The treatment group will have a physiotherapy well-being review, leading to referral to their most suitable local rehabilitation service and follow-up after 6 months. The control group will receive brief exercise advice and follow-up after 6 months. The findings will help to design a full study and be shared with patients and health professionals.
調査の概要
状態
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Sheffield、イギリス、S10 2JF
- Sheffield Teaching Sospitals NHS Foundation Trust
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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:
- in World Health Organisation (WHO) Functional Class II or III
- have a diagnosis of PH
- have started on PH drug therapy in the preceding 18 months
- showing no signs of worsening breathlessness or heart failure
- on an unchanged PH therapeutic regime for at least 6 months prior to inclusion.
Exclusion Criteria:
- have an active infection or acute exacerbation of lung disease
- have participated in a clinical study involving another investigation of drug, device or exercise within the previous 6 months
- are on a surgical or other pathway of care that has pre-determined physiotherapy or activity regimes or restrictions
- have any additional medical conditions that may adversely affect the safety of the subject or severely limit the lifespan of the subject
- have participated in rehabilitation in the last 12 months.
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：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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実験的：Intervention
The treatment group will have a physiotherapy well-being review and be referred for rehabilitation.
They will be seen after 6 months for follow-up
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For their well-being review, patients will meet with a physiotherapist specialist in PH and discuss:
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介入なし：Control
The control group will have initial assessments then receive brief advice on exercise.
They will also be followed up after 6 months
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他の：Qualitative
to understand how it feels to take part in the well-being review, we will interview some participants who have already had this kind of treatment and ask questions about their experiences of it and how it was for them.
We are also interested to know what differences they felt it made so that we can help to decide about the things we want to measure as outcomes in the interventional of the study.
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Patients who have previously undergone rehabilitation will take part in a semi-structured interview to explore their experience and the impact it has had
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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 |
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6MWD
時間枠：Follow up at 6 months
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Change from Baseline in how far he patient can walk in 6 minutes
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Follow up at 6 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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。