- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01057797
Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)
26. januar 2010 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
208
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60612
- University of Illinois at Chicago
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Aktiv 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.
|
Sham-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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Upper body strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Exercise adherence
Tidsramme: before training, after training
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before training, after training
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Janet L Larson, PhD, RN, University of Illinois at Chicago and University of Michigan
- Studieleder: Margaret K Covey, PhD, RN, University of Illinois at Chicago
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2003
Primær fullføring (Faktiske)
1. januar 2009
Studiet fullført (Faktiske)
1. januar 2009
Datoer for studieregistrering
Først innsendt
26. januar 2010
Først innsendt som oppfylte QC-kriteriene
26. januar 2010
Først lagt ut (Anslag)
27. januar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. januar 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. januar 2010
Sist bekreftet
1. januar 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NR08037
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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