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Physiotherapy in Hypoxic AECOPD Patients

2. März 2020 aktualisiert von: Marie Carmen Valenza, Universidad de Granada

Feasibility and Efficacy of Physiotherapy in Hypoxic AECOPD Patients

Hypoxia is considered a key player in many of the comorbidities that characterize COPD, such as pulmonary hypertension, skeletal muscle dysfunction, and systemic inflammation. These comorbidities are worsened during an exacerbation due to prolonged bed rest and treatment with steroids, showing a reduction in the quality of life, exercise tolerance, and a greater risk of death in these patients. Therefore, a better understanding of the safety and effectiveness of exercise training for AECOPD patients with resting hypoxemia is needed.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

36

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Spanien
    • Granada
      • Granada., Granada, Spanien, 18071
        • Rekrutierung
        • Faculty of Health Sciences. University of Granada.
        • Kontakt:
          • Marie Carmen Valenza, PT
          • Telefonnummer: 958 248035
          • E-Mail: cvalenza@ugr.es
        • Hauptermittler:
          • Marie Carmen Valenza, PT, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Patients of both sexes
  • A diagnosis of COPD made according to the criteria of the American Thoracic Society (ATS)
  • With hypoxemia at rest defined as mean arterial oxygen saturation below 90%
  • Agreed to participate

Exclusion Criteria:

  • Unstable cardiovascular disease
  • Orthopedic diseases in the upper and lower limbs
  • Being in ICU or use of mechanical ventilation
  • Motor sequelae from a neurological or cognitive impairment that interfere with the evaluation and the treatment
  • Contraindications of electrotherapy

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Global Exercise Group
all patients received the Control Group treatment added to global exercise treatment. The program included 15 minutes of deep breathing exercises and 20-30 minutes of limb exercises. The exercises included global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises. The number of repetitions was adapted to the subject's response taken into account the perceived dyspnea and fatigue during the exercise performance.
Sonstiges: Global Exercise intervention
The program included 15 minutes of deep breathing exercises and 20-30 minutes of limb exercises. The exercises included global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises
Experimental: Functional Electrostimulation Group

all patients received the Control Group treatment plus neuromuscular stimulation therapy (SEFAR Rehab X2, DJO France S.A.S., France) on quadriceps accompanied by lower limb exercises. The intervention was performed following the protocol described by Valenza et al (2017).

Valenza MC, Torres-Sánchez I, López-López L, Cabrera-Martos I, Ortiz-Rubio A, Valenza-Demet G. Effects of home-based neuromuscular electrical stimulation in severe chronic obstructive pulmonary disease patients: a randomized controlled clinical trial. Eur J Phys Rehabil Med. 2018 Jun;54(3):323-332. doi: 10.23736/S1973-9087.17.04745-1. Epub 2017 Nov 16. PubMed PMID: 29144103.
Sonstiges: Functional Electrostimulation Group

The program included a neuromuscular stimulation therapy on quadriceps accompanied by lower limb exercises. The intervention was performed following the protocol described by Valenza et al (2017).

Valenza MC, Torres-Sánchez I, López-López L, Cabrera-Martos I, Ortiz-Rubio A, Valenza-Demet G. Effects of home-based neuromuscular electrical stimulation in severe chronic obstructive pulmonary disease patients: a randomized controlled clinical trial. Eur J Phys Rehabil Med. 2018 Jun;54(3):323-332. doi: 10.23736/S1973-9087.17.04745-1. Epub 2017 Nov 16. PubMed PMID: 29144103.
Aktiver Komparator: Standard treatment
Patients received standard medical and pharmacological care that consisted in systemic steroids, inhaled bronchodilators, oxygen, and a regimen of oral prednisone or its equivalent in doses of 40 to 60 mg per day for the duration of therapy as well as anti-biotic therapy.
Sonstiges: Standard treatment
Patients received standard medical and pharmacological care that consisted in systemic steroids, inhaled bronchodilators, oxygen, and a regimen of oral prednisone or its equivalent in doses of 40 to 60 mg per day for the duration of therapy as well as anti-biotic therapy

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Lower limb strength
Zeitfenster: Baseline
Quadriceps strength was assessed with a portable hand-held dynamometer (Lafayette Manual Muscle Testing System, model 01163, Lafayette, IN, USA). The test was performed with the patient seated with his/her knees and hips flexed at 90°. Resistance was applied to the anterior tibia during 5 seconds of maximal muscle contraction. The test was repeated alternatively 3 times on the leg, allowing participants to rest between measurements. The highest value in Newton was selected for the analysis.
Baseline
Lower limb strength
Zeitfenster: Up to 9 days
Quadriceps strength was assessed with a portable hand-held dynamometer (Lafayette Manual Muscle Testing System, model 01163, Lafayette, IN, USA). The test was performed with the patient seated with his/her knees and hips flexed at 90°. Resistance was applied to the anterior tibia during 5 seconds of maximal muscle contraction. The test was repeated alternatively 3 times on the leg, allowing participants to rest between measurements. The highest value in Newton was selected for the analysis.
Up to 9 days
Balance
Zeitfenster: Baseline
Balance was evaluated by the one-leg standing balance test (OLS), that measured the time that the patient balances on one leg as long as possible. The patient choose a leg to stand on (whichever he felt more comfortable with), flex the opposite knee allowing the foot to clear the floor, and balance on one leg. Higher values mean better balance.
Baseline
Balance
Zeitfenster: Up to 9 days
Balance was evaluated by the one-leg standing balance test (OLS), that measured the time that the patient balances on one leg as long as possible. The patient choose a leg to stand on (whichever he felt more comfortable with), flex the opposite knee allowing the foot to clear the floor, and balance on one leg. Higher values mean better balance.
Up to 9 days
Dyspnea
Zeitfenster: Baseline
Dyspnea was assessed at rest using the modified Borg scale. Patients classified their breathlessness from 0 (no dyspnea) to10 (maximal dyspnea)
Baseline
Dyspnea
Zeitfenster: Up to 9 days
Dyspnea was assessed at rest using the modified Borg scale. Patients classified their breathlessness from 0 (no dyspnea) to10 (maximal dyspnea)
Up to 9 days
Fatigue
Zeitfenster: Baseline
Fatigue was evaluated using the Piper Fatigue Scale (PFS) that consists of 22 numerical items which assess multidimensional aspects of fatigue. The scale measures four dimensions of subjective fatigue: "behavioral/severity", relating to the severity, distress, and degree of disruption in activity of daily living; "affective meaning", relating to the emotional meaning attributed to fatigue; "sensory", relating to the physical symptoms of fatigue; and "cognitive/mood", relating to mental and mood states
Baseline
Fatigue
Zeitfenster: Up to 9 days
Fatigue was evaluated using the Piper Fatigue Scale (PFS) that consists of 22 numerical items which assess multidimensional aspects of fatigue. The scale measures four dimensions of subjective fatigue: "behavioral/severity", relating to the severity, distress, and degree of disruption in activity of daily living; "affective meaning", relating to the emotional meaning attributed to fatigue; "sensory", relating to the physical symptoms of fatigue; and "cognitive/mood", relating to mental and mood states
Up to 9 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universidad de Granada

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2019

Primärer Abschluss (Tatsächlich)

1. Januar 2020

Studienabschluss (Voraussichtlich)

1. April 2020

Studienanmeldedaten

Zuerst eingereicht

17. Februar 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. März 2020

Zuerst gepostet (Tatsächlich)

4. März 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. März 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. März 2020

Zuletzt verifiziert

1. März 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DF0089UG

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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