- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01057797
Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)
26 gennaio 2010 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
208
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- University of Illinois at Chicago
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
45 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Upper body strength
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Exercise adherence
Lasso di tempo: before training, after training
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before training, after training
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Janet L Larson, PhD, RN, University of Illinois at Chicago and University of Michigan
- Direttore dello studio: Margaret K Covey, PhD, RN, University of Illinois at Chicago
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2003
Completamento primario (Effettivo)
1 gennaio 2009
Completamento dello studio (Effettivo)
1 gennaio 2009
Date di iscrizione allo studio
Primo inviato
26 gennaio 2010
Primo inviato che soddisfa i criteri di controllo qualità
26 gennaio 2010
Primo Inserito (Stima)
27 gennaio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
27 gennaio 2010
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 gennaio 2010
Ultimo verificato
1 gennaio 2010
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NR08037
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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