Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
1 septembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
23
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- The Miriam Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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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Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: Cardiac rehabilitation as usual
Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Change in objectively measured time engaged in sedentary behavior
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: Change from Baseline to 16 weeks
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Change from Baseline to 16 weeks
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Lipid profile
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2016
Achèvement primaire (Réel)
1 avril 2017
Achèvement de l'étude (Réel)
1 avril 2017
Dates d'inscription aux études
Première soumission
2 février 2016
Première soumission répondant aux critères de contrôle qualité
5 février 2016
Première publication (Estimation)
10 février 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 septembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 septembre 2017
Dernière vérification
1 septembre 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 215615
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