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Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)
26 januari 2010 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
208
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- University of Illinois at Chicago
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
45 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Upper Body Strength Training with Self-Efficacy
16 weeks of upper body strength training combined with an exercise-specific self-efficacy enhancing intervention
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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.
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Actieve vergelijker: Upper body strength training
16 weeks of upper body strength training with weekly health education sessions
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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.
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Sham-vergelijker: Chair exercise
16 wks of gentle chair exercise with weekly health education
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Upper body strength
Tijdsspanne: before training, after training, 6 months post training, 12 months post training
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before training, after training, 6 months post training, 12 months post training
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Dyspnea
Tijdsspanne: before training, after training, 6 months post training, 12 months post training
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before training, after training, 6 months post training, 12 months post training
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Functional performance
Tijdsspanne: before training, after training, 6 months post training, 12 months post training
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before training, after training, 6 months post training, 12 months post training
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Exercise adherence
Tijdsspanne: before training, after training
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before training, after training
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Janet L Larson, PhD, RN, University of Illinois at Chicago and University of Michigan
- Studie directeur: Margaret K Covey, PhD, RN, University of Illinois at Chicago
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2003
Primaire voltooiing (Werkelijk)
1 januari 2009
Studie voltooiing (Werkelijk)
1 januari 2009
Studieregistratiedata
Eerst ingediend
26 januari 2010
Eerst ingediend dat voldeed aan de QC-criteria
26 januari 2010
Eerst geplaatst (Schatting)
27 januari 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
27 januari 2010
Laatste update ingediend die voldeed aan QC-criteria
26 januari 2010
Laatst geverifieerd
1 januari 2010
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NR08037
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .