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Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic

1. september 2017 opdateret af: Andrew Busch, The Miriam Hospital
Cardiac rehabilitation patients often fail to exercise as prescribed on days they are not attending rehabilitation and there is a steep drop off in exercise following rehabilitation completion. Moreover, little is known about the amount of time that cardiac rehabilitation patients spend in sedentary behavior, which is associated with increased risk of cardiovascular morbidity and mortality, independent of time spent in exercise. This pilot study aims to test acceptability, feasibility, and preliminary efficacy of a smartphone application (B-MOBILE-CARDIAC) for increasing time spent in moderate-to-vigorous intensity physical activity accumulated in bouts of at least 10 minutes in duration (i.e. bout-related MVPA) and decrease time spent in sedentary behavior. Up to 32 patients will be recruited, enrolled, and randomized during the first 2 weeks of cardiac rehabilitation to either: 1) B-MOBILE-CARDIAC plus cardiac rehabilitation or 2) cardiac rehabilitation alone. Participants will complete 7 days of objective activity monitoring to measure daily minutes spent in bout-related MVPA and sedentary behavior (primary outcomes) at baseline, mid-rehabilitation (6 weeks), end of cardiac rehabilitation (12 weeks), and 4-week follow-up (16 weeks). At these same time points, participants will complete questionnaires assessing sedentary behavior, MVPA, exercise tolerance, health-related quality of life, mood, and affect. At baseline and end of cardiac rehabilitation participants will undergo a blood draw to measure cardiometabolic and inflammatory risk factors and complete a test of cognitive functioning. Feasibility and acceptability of the B-MOBILE-CARDIAC application will be assessed at the 4-week follow-up.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • The Miriam Hospital

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. within one week of starting rehabilitation,
  2. self-report that they can walk for 10 minutes without assistance from others,
  3. were approved for and are planning to complete 12 weeks of rehabilitation,
  4. own a compatible Android phone or are willing to be taught to use one by study staff;
  5. no evidence of cognitive impairment
  6. able to speak and read English,
  7. aged 18-75 years,
  8. no known nickel allergy, and
  9. willing to follow the protocol (e.g., carry a smartphone for 16 weeks).

Exclusion Criteria:

-

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Cardiac rehabilitation as usual
Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).
Adfærdsmæssigt: Cardiac rehabilitation as usual
Eksperimentel: Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app
Participants will receive cardiac rehabilitation as usual, plus access to the B-MOBILE-CARDIAC smartphone application through 4 weeks post-rehabilitation.
Adfærdsmæssigt: Cardiac rehabilitation as usual
Andet: B-MOBILE-CARDIAC smartphone application

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in objectively measured time engaged in sedentary behavior
Tidsramme: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Tidsramme: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Change from Baseline to 12 weeks (i.e., end of rehabilitation)

Sekundære resultatmål

Resultatmål
Tidsramme
Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Self-reported sedentary behavior (SIT-Q-7d Questionnaire)
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Self-reported exercise tolerance (Duke activity status index)
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Health related quality of life (SF-12 Health Survey)
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Depressed Mood (Patient Health Questionnaire-9)
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Affect (Positive Affect Negative Affect Scales)
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Cognitive status (Montreal Cognitive Assessment score)
Tidsramme: Baseline and 12 weeks (i.e., end of rehabilitation).
Baseline and 12 weeks (i.e., end of rehabilitation).
Smartphone application acceptability (study specific scale)
Tidsramme: Baseline through 16 weeks.
Baseline through 16 weeks.
Change in objectively measured time engaged in sedentary behavior
Tidsramme: Change from Baseline to 16 weeks
Change from Baseline to 16 weeks
Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Tidsramme: Change from Baseline to 16 weeks
Change from Baseline to 16 weeks
Lipid profile
Tidsramme: Baseline and 12 weeks (i.e., end of rehabilitation)
Baseline and 12 weeks (i.e., end of rehabilitation)
C-reactive protein
Tidsramme: Baseline and 12 weeks (i.e., end of rehabilitation)
Baseline and 12 weeks (i.e., end of rehabilitation)
haemoglobin A1c (HbA1C)
Tidsramme: Baseline and 12 weeks (i.e., end of rehabilitation)
Baseline and 12 weeks (i.e., end of rehabilitation)
Blood pressure
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Waist circumference
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Body Mass Index (kg/m^2, weight in kilograms, height in meters)
Tidsramme: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Miriam Hospital

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. marts 2016

Primær færdiggørelse (Faktiske)

1. april 2017

Studieafslutning (Faktiske)

1. april 2017

Datoer for studieregistrering

Først indsendt

2. februar 2016

Først indsendt, der opfyldte QC-kriterier

5. februar 2016

Først opslået (Skøn)

10. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 215615

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 .

Kliniske forsøg med Hjertefejl

Kliniske forsøg med Cardiac rehabilitation as usual

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