Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic response, pulmonary function and exercise capacity.
Non-pharmacological interventions are low cost and can significant enhance outcomes in these patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable therapeutic approach in patients with functional limitations, particularly those that present with difficulty to perform exercise protocols.
Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality of life of patients with PH.
Material and methods: prospective randomized controlled study with a control group (GC, n9) and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk test (6MWT) were assessed before and after the NMES protocol.
Results: the GE presented with a significant improvement in distance walked in the 6MWT, cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and social aspects of the questionnaire Short Form Health Survey-36.
Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved exercise capacity, quality of life and lung function testing.
調査の概要
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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Sao Paulo、ブラジル、01221-020
- Santa Casa of Sao Paulo Medical School
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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:
Males and females greater than or equal to 18 years of age, clinically stable with optimized drug therapy in the last 3 months, previously diagnosed with a mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization and who agreed to participate by signing an informed consent were included.
Exclusion Criteria:
Exclusion criteria included a diagnosis of Down syndrome, orthopedic disease or neurologic or diagnoses, history of acute heart attack, use of beta-blockers, any urgent or elective surgical intervention during the implementation of the protocol, those who used assistive devices to ambulate or develop an infectious process during the study protocol.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control Group (GC)
The GC received standard ambulatory care, including routine exams and drug therapy.
All patients were reassessed after the 2 month protocol.
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実験的：NMES Group (GE)
Receiving the usual care and guidance on their illness, underwent 30 minute NMES sessions twice a week for two months using an electrostimulator.
Specifically, 5 cm adhesive surface electrodes in four alternate channels on the Rectus Femoris (two channels the right and two on the left) were used to deliver two-phase symmetrical currents, with a rectangular pulse wave at a frequency of 35 Hz and pulse duration of 250 μ.
The time of ascent and descent was one second, contraction time was four seconds and relaxation was eight seconds.
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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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Distance in six-minute walk test
時間枠：change from baseline in distance at 2 months
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analysis of distance
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change from baseline in distance at 2 months
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Oxygen saturation in six-minute walk test
時間枠：change from baseline in oxygen saturation at 2 months
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analysis of oxygen saturation at end of test
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change from baseline in oxygen saturation at 2 months
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Systolic blood pressure in six-minute walk test
時間枠：change from baseline in systolic blood pressure at 2 months
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analysis of systolic blood pressure at end of test
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change from baseline in systolic blood pressure at 2 months
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Diastolic blood pressure in six-minute walk test
時間枠：change from baseline in diastolic blood pressure at 2 months
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analysis of diastolic blood pressure at end of test
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change from baseline in diastolic blood pressure at 2 months
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Heart rate in six-minute walk test
時間枠：change from baseline in heart rate at 2 months
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analysis of heart rate at end of test
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change from baseline in heart rate at 2 months
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Borg scale in six-minute walk test
時間枠：change from baseline in Borg scale at 2 months
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analysis of Borg scale at end of test
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change from baseline in Borg scale at 2 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 |
|---|---|---|
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The Medical Outcomes Study 36-item Short Form Health Survey
時間枠：change from baseline at 2 months
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The questionnaire covers 36 items, designed to assess health concepts
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change from baseline at 2 months
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Forced vital capacity
時間枠：change from baseline at 2 months
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spirometric analysis
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change from baseline at 2 months
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Forced expiratory volume in the first second
時間枠：change from baseline at 2 months
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spirometric analysis
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change from baseline at 2 months
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Forced expiratory flow 25-75 %
時間枠：change from baseline at 2 months
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spirometric analysis
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change from baseline at 2 months
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Ratio of forced expiratory volume in the first second and forced vital capacity
時間枠：change from baseline at 2 months
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spirometric analysis
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change from baseline at 2 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
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
本研究に関する用語
その他の研究ID番号
- Parece 517.472
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。
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