Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
1 september 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
23
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02903
- The Miriam Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- within one week of starting rehabilitation,
- self-report that they can walk for 10 minutes without assistance from others,
- were approved for and are planning to complete 12 weeks of rehabilitation,
- own a compatible Android phone or are willing to be taught to use one by study staff;
- no evidence of cognitive impairment
- able to speak and read English,
- aged 18-75 years,
- no known nickel allergy, and
- willing to follow the protocol (e.g., carry a smartphone for 16 weeks).
Exclusion Criteria:
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Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Cardiac rehabilitation as usual
Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).
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Experimenteel: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change in objectively measured time engaged in sedentary behavior
Tijdsspanne: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Tijdsspanne: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Self-reported sedentary behavior (SIT-Q-7d Questionnaire)
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Self-reported exercise tolerance (Duke activity status index)
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Health related quality of life (SF-12 Health Survey)
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Depressed Mood (Patient Health Questionnaire-9)
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Affect (Positive Affect Negative Affect Scales)
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Cognitive status (Montreal Cognitive Assessment score)
Tijdsspanne: Baseline and 12 weeks (i.e., end of rehabilitation).
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Baseline and 12 weeks (i.e., end of rehabilitation).
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Smartphone application acceptability (study specific scale)
Tijdsspanne: Baseline through 16 weeks.
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Baseline through 16 weeks.
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Change in objectively measured time engaged in sedentary behavior
Tijdsspanne: Change from Baseline to 16 weeks
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Change from Baseline to 16 weeks
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Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Tijdsspanne: Change from Baseline to 16 weeks
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Change from Baseline to 16 weeks
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Lipid profile
Tijdsspanne: Baseline and 12 weeks (i.e., end of rehabilitation)
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Baseline and 12 weeks (i.e., end of rehabilitation)
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C-reactive protein
Tijdsspanne: Baseline and 12 weeks (i.e., end of rehabilitation)
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Baseline and 12 weeks (i.e., end of rehabilitation)
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haemoglobin A1c (HbA1C)
Tijdsspanne: Baseline and 12 weeks (i.e., end of rehabilitation)
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Baseline and 12 weeks (i.e., end of rehabilitation)
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Blood pressure
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Waist circumference
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Body Mass Index (kg/m^2, weight in kilograms, height in meters)
Tijdsspanne: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2016
Primaire voltooiing (Werkelijk)
1 april 2017
Studie voltooiing (Werkelijk)
1 april 2017
Studieregistratiedata
Eerst ingediend
2 februari 2016
Eerst ingediend dat voldeed aan de QC-criteria
5 februari 2016
Eerst geplaatst (Schatting)
10 februari 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 september 2017
Laatste update ingediend die voldeed aan QC-criteria
1 september 2017
Laatst geverifieerd
1 september 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 215615
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