The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease
2026年7月22日 更新者：Daniel Lachant、University of Rochester
This study evaluates the effects of a structured home exercise program in participants with pulmonary hypertension associated with interstitial lung disease.
Participants will complete a defined exercise regimen over a 16-week period, and functional capacity and patient reported outcomes will be assessed at baseline and after the intervention.
The study aims to determine whether a home-based exercise approach is feasible and associated with improvements in functional performance.
調査の概要
状態
募集
詳細な説明
Pulmonary hypertension associated with interstitial lung disease is associated with reduced exercise capacity, decreased quality of life, and increased morbidity. Exercise based interventions may improve functional status in this population; however, access to supervised rehabilitation programs may be limited. Home based exercise programs offer a potentially accessible alternative, but their feasibility and effectiveness in this population are not well established.
In this interventional study, participants with pulmonary hypertension associated with interstitial lung disease will be enrolled and assigned to a structured home exercise program. The intervention will be performed over a 16-week period. Participants will undergo baseline assessments prior to starting the exercise program and follow up assessments at the end of the intervention period.
Assessments will include measures of functional capacity and patient reported outcomes collected using standardized methods. The primary objective is to evaluate changes in functional performance following completion of the home exercise program. Secondary objectives include evaluation of participant reported outcomes and feasibility of the intervention.
研究の種類
介入
入学 (推定)
30
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。
研究連絡先
- 名前：Daniel Lachant, DO
- 電話番号：585 273 4608
- メール：Daniel_Lachant@urmc.rochester.edu
研究場所
-
-
New York
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Rochester、New York、アメリカ、14642
- 募集
- University of Rochester Medical Center
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主任研究者：
- Daniel Lachant, DO
-
コンタクト：
- Daniel Lachant, DO
- 電話番号：5852734608
- メール：daniel_lachant@urmc.rochester.edu
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Follows at University of Rochester Medical Center Pulmonary Hypertension Clinic.
- Adult patients (>18 years old) with right heart catheterization confirmed pulmonary hypertension interstitial lung disease on stable therapy dosing for at least 30 days.
- Access to a smart phone or email to receive daily messages.
- Clinically stable by the investigator.
Exclusion Criteria:
- Pregnancy.
- Pulmonary Hypertension Groups 1,2,4,5.
- Resting tachycardia >120 beats/m during screening.
- Inability to walk.
- WHO Functional Class IV
- Lack of access to email or text messaging.
- Participating in a rehabilitation program.
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：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：Aerobic Plus Strength Training
Participants receive 16 weeks of structured daily exercise messages for aerobic and strength training activities with heart rate guidance.
Participants also receive resistance bands and ankle weights.
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Structured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic and strength training activities with heart rate guidance.
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アクティブコンパレータ：Aerobic only
Participants receive 16 weeks of structured daily aerobic exercise messages with heart rate guidance.
Participants may perform walking or Cubii-based aerobic exercise.
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Structured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic activities with heart rate guidance.
|
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 |
|---|---|---|
|
Mean Change in Cardiac Effort From Baseline to 16 Weeks
時間枠：Baseline to 16 weeks
|
Cardiac Effort is measured as the ratio of the total number of heart beats recorded during the Six Minute Walk Test to the total distance walked in meters.
Heart rate is continuously monitored during the test using a validated heart rate monitoring device.
The value represents the number of heart beats required per unit distance walked (beats per meter).
Individual participant values are calculated at baseline and at 16 weeks.
The outcome is defined as the mean change in Cardiac Effort from baseline to 16 weeks across participants.
Lower values indicate improved cardiac efficiency and better functional performance, while higher values indicate reduced efficiency and worse functional status.
|
Baseline to 16 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change in Six Minute Walk Distance From Baseline to 16 Weeks
時間枠：Baseline to 16 weeks
|
Six Minute Walk Distance is measured using the standardized Six Minute Walk Test according to established clinical guidelines.
The total distance walked in meters during six minutes is recorded for each participant.
Individual participant values are collected at baseline and at 16 weeks.
The outcome is defined as the mean change in distance walked from baseline to 16 weeks across participants.
Higher values indicate improved functional capacity, while lower values indicate reduced exercise tolerance.
|
Baseline to 16 weeks
|
|
Mean Change in emPHasis-10 Score From Baseline to 16 Weeks
時間枠：Baseline to 16 weeks post intervention
|
Quality of life is measured using the emPHasis-10 questionnaire, a validated patient reported outcome instrument specific to pulmonary hypertension.
The questionnaire consists of 10 items assessing symptoms and impact on daily life.
Scores range from 0 to 50, with higher scores indicating worse health related quality of life.
Individual participant scores are calculated by summing item responses.
The outcome is defined as the mean change in total score from baseline to 16 weeks across participants.
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Baseline to 16 weeks post intervention
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Mean Change in King's Brief Interstitial Lung Disease Questionnaire Score From Baseline to 16 Weeks
時間枠：Baseline to 16 weeks
|
Quality of life is measured using the King's Brief Interstitial Lung Disease questionnaire, a validated instrument assessing health status in interstitial lung disease.
Scores range from 0 to 100, with higher scores indicating better health status.
Individual participant scores are calculated according to standard scoring procedures.
The outcome is defined as the mean change in score from baseline to 16 weeks across participants.
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Baseline to 16 weeks
|
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Mean Change in Lower Extremity Muscle Strength From Baseline to 16 Weeks
時間枠：Baseline to 16 weeks
|
Muscle strength is measured using a Lafayette Muscle Dynamometer for quadriceps strength and a Jamar Hand Dynamometer for hand grip strength.
Measurements are recorded in pounds (lbs) for each participant.
Individual participant values are obtained at baseline and at 16 weeks.
The outcome is defined as the mean change in muscle strength from baseline to 16 weeks across participants.
Higher values indicate greater muscle strength, while lower values indicate reduced strength.
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Baseline to 16 weeks
|
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Number of Participants With Healthcare Utilization Events During the 16 Week Study Period
時間枠：From enrollment to 16 weeks
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Healthcare utilization events include unplanned medical visits such as emergency department visits, hospitalizations, and clinic visits occurring during the study period.
Events are collected through participant self report and study follow up.
The outcome is defined as the number of participants experiencing at least one healthcare utilization event during the study period.
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From enrollment to 16 weeks
|
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Number of Participants With Falls During the 16 Week Study Period
時間枠：From enrollment to 16 weeks
|
Falls are defined as any unintentional event resulting in a participant coming to rest on the ground or a lower level.
Falls are self reported by participants during weekly check-ins throughout the study period.
The outcome is defined as the number of participants experiencing at least one fall during the study period.
|
From enrollment to 16 weeks
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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。
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)
2026年7月15日
一次修了 (推定)
2027年5月30日
研究の完了 (推定)
2027年5月30日
試験登録日
最初に提出
2026年4月24日
QC基準を満たした最初の提出物
2026年4月24日
最初の投稿 (実際)
2026年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月24日
QC基準を満たした最後の更新が送信されました
2026年7月22日
最終確認日
2026年4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。