- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03922022
Exercise is Medicine: a Pilot Study
Exercise is Medicine for Chronic Diseases: a Pilot Study for Future Randomized Controlled Trial
Background: Regular exercise is beneficial to patients with hypertension and/or diabetes mellitus. However, most patients cannot maintain exercise habit. The investigators had developed a program called the "exercise is medicine"(EIM), combining motivational technique, information technology use and teaching exercise techniques. Before using this intervention in a main randomized controlled trial, the investigators would like to test its feasibility and acceptability. It is hypothesized that this program is feasible and acceptable to patients.
Method: 40 patients with HT and/or DM will be recruited to attend the EIM intervention. Primary outcomes will be the rate of recruitment and rate of retention. Other clinical outcomes will be obtained before and immediately after the 12-week program.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Hong Kong, Hong Kong
- Lek Yuen Clinic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- clinic systolic BP(SBP) higher than 130mmHg (for HT class) because the Hong Kong primary care office guideline, as of Jan 2019, regarded good control of SBP to be ≤130mmHg, OR HbA1c >7% (for DM class)
- self-reported regular exercise of ≤3 times per week - this cut-off is arbitrary but people who exercise more than 3 times may have little space for improvement; and these patients will unlikely be referred to EIM when it is implemented in routine clinical practice, - who have used any mobile apps on their phone (because the intervention involve use of apps to monitor and remind regular exercise)
Exclusion Criteria:
- patients with diagnosed chronic obstructive lung disease and recent stroke (within last 12 months) are excluded because there are other evidence-proven and well-structured programmes for these patients in the Hospital Authority (HA), for instance, pulmonary rehabilitation program conducted by physiotherapy and/or occupational therapist in HA. - - acute myocardial infarction in last 6 months
- ongoing angina
- uncontrolled cardiac arrhythmia
- acute diseases including known active endocarditis/acute pulmonary embolism, pulmonary infarction, deep vein thrombosis, acute aortic dissection, acute myocarditis
- known aortic stenosis
- known heart failure
- known obstructive left main coronary artery stenosis
- uncontrolled ventricular rates
- complete heart block
- known hypertrophic obstructive cardiomyopathy
- mental impairment that limit co-operation
- resting blood pressure with systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg
- known anaemia with haemoglobin level less than 11gm/dL
- known uncorrected electrolyte imbalance
- known uncontrolled hyperthyroidism.
- For DM patients, patients with proliferative diabetic retinopathy and recent retinal bleeding (in last 12 months) are also excluded due to reports that vigorous exercise may increase blood pressure and led to retinal bleeding in these patients
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: EIM group
patients will go to different classes: (i) Hypertension basic exercise class (ii) Hypertension advanced exercise class (iii) diabetes basic exercise class (iv) diabetes advanced exercise class; if the patient has normal BMI AND reported some regular exercise, they will be prescribed the advanced level class.
There is no control group for this pilot study
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This is a complex intervention.
On recruitment, they will be seen by a nurse and counselled using motivational technique.
They will then undergo a 12-week class.
The exercise levels will be regularly feedback to the patients by use of mobile devices and trackers.
Peer support is formed during the 12-week class.
Resources to continue exercise will be provided to patients.
Regular monitoring of physical improvement will be feedback to patients to encourage continued exercise.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
rate of retention
Délai: from recruitment to finish of the 12-week program
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rate of retention
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from recruitment to finish of the 12-week program
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Rate of recruitment
Délai: from recruitment to the start of the 12-week program
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Rate of recruitment
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from recruitment to the start of the 12-week program
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Clinic blood pressure (BP)
Délai: on recruitment and after the 12- week class
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Clinical BP will be measured 3 times and the last 2 will be averaged
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on recruitment and after the 12- week class
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HbA1c (glycosylated hemoglobin)
Délai: on recruitment and after the 12- week class
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for DM patients only
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on recruitment and after the 12- week class
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Godin-Shephard Laiesure-Time Physical Activity Questoinnaire
Délai: on recruitment and after the 12- week class
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a validated questionnaire to detect change in exercise level
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on recruitment and after the 12- week class
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body mass index (BMI)
Délai: on recruitment and after the 12- week class
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the weight and height of the patients will be measured
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on recruitment and after the 12- week class
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body fat percentage
Délai: on recruitment and after the 12- week class
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body fat percentage
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on recruitment and after the 12- week class
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lipid level
Délai: on recruitment and after the 12- week class
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this will include low-density lipoprotein, high-density lipoprotein, and total lipoprotein
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on recruitment and after the 12- week class
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9-item patient health questionnaire
Délai: on recruitment and after the 12- week class
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a validated questionnaire to detect depressive symptoms
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on recruitment and after the 12- week class
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Generalized anxiety disorder-7
Délai: on recruitment and after the 12- week class
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a validated questionnaire to detect anxiety symptoms
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on recruitment and after the 12- week class
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EQ-5D-5L
Délai: on recruitment and after the 12- week class
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a validated questionnaire to measure quality of life
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on recruitment and after the 12- week class
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NTEC-2019-0121
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur Hypertension
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National Taiwan University Hospital Hsin-Chu BranchRecrutementHypertension Essentielle | Hypertension, masquéTaïwan
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University of Alabama at BirminghamTroy UniversityComplétéHypertension | Hypertension, résistante à la thérapie conventionnelle | Hypertension non contrôlée | Hypertension, blouse blancheÉtats-Unis
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Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentInconnue
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Vanderbilt University Medical CenterJohns Hopkins UniversityComplétéHypertension artérielle pulmonaire | Hypertension artérielle pulmonaire idiopathique | Hypertension artérielle pulmonaire associée | Hypertension artérielle pulmonaire héréditaireÉtats-Unis
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Centre Chirurgical Marie LannelongueInconnueHypertension pulmonaire thromboembolique chronique et hypertension artérielle pulmonaireFrance
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Assistance Publique - Hôpitaux de ParisActif, ne recrute pasHypertension portale non cirrhotique intrahépatiqueFrance
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University of Kansas Medical CenterRecrutementHypertension artérielle pulmonaire | Hypertension pulmonaire | Hypertension pulmonaire thromboembolique chronique | Hypertension pulmonaire due à une cardiopathie gauche | Hypertension pulmonaire, primaire, 4 | Hypertension pulmonaire, primaire, 2 | Hypertension pulmonaire, primaire, 3 | Hypertension... et d'autres conditionsÉtats-Unis
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Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldComplétéHypertension artérielle pulmonaire idiopathique | Hypertension pulmonaire thromboembolique chroniqueRoyaume-Uni
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BayerComplété
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AstraZenecaComplétéHypertension artérielle (hypertension).
Essais cliniques sur EIM exercise classes and intervention
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Children's Hospital Medical Center, CincinnatiComplété
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University of British ColumbiaSocial Sciences and Humanities Research Council of CanadaComplété
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access LivingActif, ne recrute pas
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Universiteit AntwerpenAmref Health AfricaComplétéÉpilepsie | OnchocercoseSoudan du sud
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VA Office of Research and DevelopmentRetiréTroubles du sommeil et de l'éveil | Trouble du sommeil | Troubles liés au sommeilÉtats-Unis
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GlaxoSmithKlineComplétéTétanos | Diphtérie | Coqueluche acellulaireÉtats-Unis