- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00467298
An Intervention to Improve Function in Severe Cardiopulmonary Illness
30. august 2017 opdateret af: VA Office of Research and Development
An Intervention to Enhance Function in Severe Cardiopulmonary Illness
The study is a randomized trial of a cardiopulmonary self-management intervention to improve functional capacity, health-related quality of life, and to reduce health care utilization.
Two hundred (100 in each group) will be recruited from VA Puget Sound Health Care System over four years.
Outcomes will be measured at three points: at entry, at the end of the 6 month intervention, and 12 months after entry.
Change in functional capacity at the end of the intervention program is the primary outcome.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This study is a randomized, controlled trial of a cardiopulmonary exercise and self-management intervention to improve functional capacity, health related-related quality of life, and to reduce health care costs in medically fragile, elderly patients with chronic obstructive pulmonary disease (COPD) or heart failure (HF).
Specific aims include: (1) To determine the benefits of a combined outpatient/home-based exercise, self-management program on function al capability (daily activity, six-minute walk distance, symptoms), (2) to determine the effects of exercise/self-management on quality of life, health status, cardiopulmonary function, and gait and balance, (3) to test the theoretical self-regulation model for mediating effects on major outcome variables, and (4) to compare health care resource utilization and expenditures between the intervention and usual care groups in order to conduct a cost-effectiveness analysis of the program.
The primary outcome upon which the study is powered is functional capability measured by daily physical activity.
Outcomes will be measured at three time points: at entry and following the intervention at 6 and 12 months.
Two-hundred (100/group) will be recruited from the VA Puget Sound Health Care System outpatient clinics.
The study will be carried out over four years.
Inclusion criteria include standard criteria for severe COPD or HF, optimal medical management, willingness to participate in an outpatient exercise/self-management program, working phone, hospitalization for HF, COPD, or related illness in the past two years or at least two outpatient visits for same over the past year.
Exclusion criteria include unstable disease or recent surgery, supplemental oxygen requirement at rest more than 4 LPM, already participating in regular exercise three times a week, inability to ambulate, uncontrolled mental illness, alcohol or drug abuse and life expectancy less than one year.
The intervention consists of a month long program of two 2-hour visits a week incorporating equal time for endurance and strength training as well as individually-tailored instruction in self-management of their heart/lung disease.
Usual care control is an 8-week standard cardiopulmonary exercise program, two days a week for an hour with some self-management content.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98101
- VA Puget Sound Health Care System
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- standard criteria for severe COPD or HF,
- optimal medical management,
- willingness to participate in an outpatient exercise/self-management program,
- working phone,
- hospitalization for HF, COPD, or related illness in the past two years or at least two unscheduled outpatient visits for same over the past year
Exclusion Criteria:
- unstable disease or recent surgery,
- supplemental oxygen requirement at rest more than 4 LPM,
- already participating in regular exercise three times a week,
- inability to ambulate,
- uncontrolled mental illness,
- alcohol or drug abuse,
- life expectancy less than one year
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Self-management
Novel intensive self-management education and exercise program of four weeks
|
The exercise program includes endurance and strength training and warm-up and cool-down strategies.
Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.
Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.
This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions.
|
Ingen indgriben: Usual care
Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Function Capability
Tidsramme: 6 months
|
6MWT-Six Minute Walk Test
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of Life
Tidsramme: 6 months
|
SF-36 PCS.
Scale range 0-100, higher scores reflect higher quality of life.
PCS=Physical Composite Score.
These are not change scores.
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Bonnie G. Steele, PhD RN, VA Puget Sound Health Care System
- Ledende efterforsker: Cynthia M. Dougherty, PhD RN, VA Puget Sound Health Care System, Seattle
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5.
- Steele BG, Belza B, Cain KC, Coppersmith J, Lakshminarayan S, Howard J, Haselkorn JK. A randomized clinical trial of an activity and exercise adherence intervention in chronic pulmonary disease. Arch Phys Med Rehabil. 2008 Mar;89(3):404-12. doi: 10.1016/j.apmr.2007.11.003.
- Steele BG, Cain K, Coppersmith J, Belza B, Howard J, Lakshminarayan S. Pulmonary rehabilitation (PR) outcomes in chronic obstructive pulmonary disease (COPD): Are benefits equivalent in end-stage disease? Proceedings of the American Thoracic Society. 2008 May 17; 177:A446.
- Steele BG, Belza B, Cain K, Coppersmith J, Howard J, Lakshminarayan S, Haselkorn J. The impact of chronic obstructive pulmonary disease exacerbation on pulmonary rehabilitation participation and functional outcomes. J Cardiopulm Rehabil Prev. 2010 Jan-Feb;30(1):53-60. doi: 10.1097/HCR.0b013e3181c85845.
- Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:301-13. doi: 10.2147/copd.s6643. Epub 2009 Sep 1.
- Dougherty CM, Steele BG, Hunziker J. Testing an intervention to improve functional capability in advanced cardiopulmonary illness. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):35-41. doi: 10.1097/HCR.0b013e3181f1fd77.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2007
Primær færdiggørelse (Faktiske)
1. december 2011
Studieafslutning (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
25. april 2007
Først indsendt, der opfyldte QC-kriterier
27. april 2007
Først opslået (Skøn)
30. april 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NRI 04-242
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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