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Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)

26. Januar 2010 aktualisiert von: University of Illinois at Chicago

Nurse Managed Upper Body Strength Training in COPD

This is a four month exercise training program for people with chronic obstructive pulmonary disease (COPD)with a 12 month follow-up.

Studienübersicht

Detaillierte Beschreibung

People with moderate to severe chronic obstructive pulmonary disease (COPD) experience intense symptoms of dyspnea when they use their arms and shoulders. To control dyspnea they avoid using their arms and ultimately experience a significant loss of upper body (UB) strength and a decrease in the level of physical activity. Some pulmonary rehabilitation programs include strength training, but the training intensity is typically very low. The purpose of this research is to examine the effects of UB strength training (designed to maximize strength gains) with a self-confidence intervention to enhance adherence to exercise. This is an experimental study with random assignment of subjects to one experimental and two control groups: (a) UB strength training and self-efficacy intervention for adherence (experimental), (b) UB strength training with health education (control 1) and (c) gentle armchair fitness exercises with health education (control 2). Each subject will be studied for a total of 16 months.The intervention period is four months in duration with a 12-month follow-up period. The sample will be people with moderate to severe COPD who experience dyspnea with UB activities. This research is innovative in that it examines the effects of upper body strength training designed to maximize strength gains and combines it with a theory-based self-efficacy (confidence-building) intervention to promote adherence to training in people with COPD.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

208

Phase

  • Phase 2

Kontakte und Standorte

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

Studienorte

    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • University of Illinois at Chicago

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

45 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • FEV1/FVC < 70 and FEV1 < 80%
  • > or = 45 years of age
  • Currently in stable clinical condition [free of respiratory tract infections for at least two months prior to enrollment, no recent change in the color, consistency, or quantity of sputum, afebrile and no recent change in medical therapy]
  • Taking appropriate medications according to the GOLD standards
  • Experience dyspnea with the use of their arms.

Exclusion Criteria:

  • Evidence of restrictive lung disease or asthma
  • Acute respiratory infection
  • Taking oral corticosteroids on a regular basis
  • >3 exacerbations in the previous year
  • Evidence of significant depression (Hospital Anxiety Depression Scale >10)
  • Presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis, evidence of alcohol or drug abuse, diabetes requiring insulin therapy, musculoskeletal or degenerative nerve disease, etc.
  • Presence of a condition that would make it potentially unsafe to exercise, including a history of a recent myocardial infarction, unstable angina pectoris, uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, severe symptomatic aortic stenosis, uncontrolled symptomatic heart failure, uncontrolled metabolic disease, abnormal response to exercise test
  • Currently participating in pulmonary rehabilitation.

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: Upper Body Strength Training with Self-Efficacy
16 weeks of upper body strength training combined with an exercise-specific self-efficacy enhancing intervention
Subjects in the experimental group will participate in a self-efficacy enhancing intervention designed to maximize (a) exercise-specific SE-UB strength training (b) self-efficacy for overcoming barriers to exercise and (c) SE-UB physical activities. The intervention incorporates strategies to maximize the primary sources of efficacy information: (a) mastery accomplishments, (b) social modeling, (c) social persuasion, (d) interpretation of physiological and affective symptoms.
16 weeks of lab-based upper body strength training using 8: modified lateral pull down, shoulder shrug, upright row, overhead pull down, front raise, front pull down, triceps extension, biceps curl. Training load and volume will be increased progressing from 70% to 80% of the maximum strength training and from 2 sets of 8-10 repetitions progressing to 3 sets. Each week subjects will train twice in the lab and once at home. Home exercises will include 1 set of 15-20 repetitions: biceps curl, triceps extension, front raises, lateral raises, overhead press, chest press and one-arm dumbbell row.
Aktiver Komparator: Upper body strength training
16 weeks of upper body strength training with weekly health education sessions
16 weeks of lab-based upper body strength training using 8: modified lateral pull down, shoulder shrug, upright row, overhead pull down, front raise, front pull down, triceps extension, biceps curl. Training load and volume will be increased progressing from 70% to 80% of the maximum strength training and from 2 sets of 8-10 repetitions progressing to 3 sets. Each week subjects will train twice in the lab and once at home. Home exercises will include 1 set of 15-20 repetitions: biceps curl, triceps extension, front raises, lateral raises, overhead press, chest press and one-arm dumbbell row.
Schein-Komparator: Chair exercise
16 wks of gentle chair exercise with weekly health education
Gentle armchair fitness exercises will be used as a sham treatment to control for the attention that subjects receive in the two strength training groups. The armchair fitness exercises will be conducted in small groups (n=8-10 per group). Armchair exercises will include stretching of all major joints with an emphasis on the arms and shoulders, massage of muscles that can be reached from the armchair (scalp, neck, shoulders, lower back, abdomen and thighs) and imagery to promote relaxation. Each session will include: 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery for relaxation.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Upper body strength
Zeitfenster: before training, after training, 6 months post training, 12 months post training
before training, after training, 6 months post training, 12 months post training
Dyspnea
Zeitfenster: before training, after training, 6 months post training, 12 months post training
before training, after training, 6 months post training, 12 months post training
Functional performance
Zeitfenster: before training, after training, 6 months post training, 12 months post training
before training, after training, 6 months post training, 12 months post training

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Exercise adherence
Zeitfenster: before training, after training
before training, after training

Mitarbeiter und Ermittler

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

Ermittler

  • Hauptermittler: Janet L Larson, PhD, RN, University of Illinois at Chicago and University of Michigan
  • Studienleiter: Margaret K Covey, PhD, RN, University of Illinois at Chicago

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

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

1. September 2003

Primärer Abschluss (Tatsächlich)

1. Januar 2009

Studienabschluss (Tatsächlich)

1. Januar 2009

Studienanmeldedaten

Zuerst eingereicht

26. Januar 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Januar 2010

Zuerst gepostet (Schätzen)

27. Januar 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

27. Januar 2010

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Januar 2010

Zuletzt verifiziert

1. Januar 2010

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

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