Tai Chi Mind-Body Therapy for Chronic Heart Failure (NEXT-Heart)
23. februar 2017 opdateret af: Gloria Y. Yeh, Beth Israel Deaconess Medical Center
The purpose of this study is to determine the effects of a tai chi exercise program on functional capacity and health-related quality of life in patients with chronic heart failure (HF).
This study will also examine the way tai chi influences mental, physical, and social functioning.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
HF is a major public health problem in the United States, affecting approximately 5 million adults. Despite recent advances in pharmacologic therapy and technologic devices, HF is the most common reason for hospitalization among Medicare patients and is reaching epidemic proportions as the population ages. New and inexpensive interventions that can improve functional capacity and quality of life and can delay disease progression are needed. Tai chi is a popular mind-body exercise that is a potential treatment for heart disease. This exercise incorporates both gentle physical activity and meditation, and it may be particularly suited to frail patients with HF. This study will examine the effects of a tailored tai chi program on functional capacity and quality of life in patients with HF.
Participants will be randomly assigned to either a tai chi program or heart health education for 12 weeks. Participants in both groups will undergo a bicycle stress test at study entry and will receive weekly training sessions of their assigned intervention. Self-report scales and questionnaires will be used to assess participants at study start and at the end of 12 weeks.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, Forenede Stater, 02215
- Brigham and Women's Hospital
-
Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center, Harvard Medical School
-
Brookline, Massachusetts, Forenede Stater, 02446
- Lown Cardiovascular Center
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis of chronic HF
- Percentage of blood pumped from the left ventricle (ventricular ejection fraction) less than 40% for at least 1 year prior to study entry
- Stable medical regimen, defined as no major changes in medication, in the 3 months prior to study entry
- New York Heart Association Classification of Class I (no activity limitations), Class II (slight activity limitations), or Class III (marked activity limitations)
- English-speaking
Exclusion Criteria:
- Unstable angina, myocardial infarction, cardiac resynchronization, or major cardiac surgery within 3 months prior to study entry
- History of cardiac arrest or diagnosis of peripartum cardiomyopathy within 6 months prior to study entry
- Unstable ventricular arrhythmias or structural valvular disease
- Current participation in a conventional cardiac rehabilitation program
- Inability to perform a bicycle stress test at study entry
- Lower extremity amputation or other inability to walk due to conditions other than HF
- Severe cognitive dysfunction preventing informed consent and understanding of tai chi concept
- Current regular practice of tai chi
- Current participation in a tai chi pilot study or other studies
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tai Chi
12-week tai chi program
|
24 tai chi sessions.
2 sessions/week for 12 weeks.
|
|
Aktiv komparator: Heart Health Education
12-week attention control
|
24 Educational sessions.
2 sessions/week for 12 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
HF-specific quality of life
Tidsramme: baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
functional capacity
Tidsramme: baseline and endpoint
|
baseline and endpoint
|
|
Walking Test
Tidsramme: baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
General quality of life
Tidsramme: baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
mood and emotional status
Tidsramme: baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
exercise self-efficacy
Tidsramme: baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
sense of coherence
Tidsramme: baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
utility assessment
Tidsramme: baseline, midpoint, endpoint, 6mo
|
baseline, midpoint, endpoint, 6mo
|
|
beliefs, attitudes, and expectations
Tidsramme: baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
|
physical activity level
Tidsramme: baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
|
perceived social support
Tidsramme: baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
|
neurohormonal status
Tidsramme: baseline, midpoint, endpoint
|
baseline, midpoint, endpoint
|
|
autonomic tone, heart rate variability
Tidsramme: baseline and endpoint
|
baseline and endpoint
|
|
echocardiography
Tidsramme: baseline and endpoint
|
baseline and endpoint
|
|
costs and use of HF services
Tidsramme: baseline and endpoint
|
baseline and endpoint
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Russell S. Phillips, MD, Beth Israel Deaconess Medical Center, Harvard Medical School
- Studieleder: Ellen P. McCarthy, PhD, Beth Israel Deaconess Medical Center, Harvard Medical School
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
- Yeh GY, Wood MJ, Lorell BH, Stevenson LW, Eisenberg DM, Wayne PM, Goldberger AL, Davis RB, Phillips RS. Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial. Am J Med. 2004 Oct 15;117(8):541-8. doi: 10.1016/j.amjmed.2004.04.016.
- Yeh GY, McCarthy EP, Wayne PM, Stevenson LW, Wood MJ, Forman D, Davis RB, Phillips RS. Tai chi exercise in patients with chronic heart failure: a randomized clinical trial. Arch Intern Med. 2011 Apr 25;171(8):750-7. doi: 10.1001/archinternmed.2011.150.
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. september 2005
Primær færdiggørelse (Faktiske)
1. januar 2009
Studieafslutning (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først indsendt
4. maj 2005
Først indsendt, der opfyldte QC-kriterier
4. maj 2005
Først opslået (Skøn)
5. maj 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. februar 2017
Sidst verificeret
1. februar 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2004P000390
- R01AT002454 (U.S. NIH-bevilling/kontrakt)
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 .