- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Hong Kong, Hong Kong
- Lek Yuen Clinic
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
rate of retention
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Clinic blood pressure (BP)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NTEC-2019-0121
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su EIM exercise classes and intervention
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Indiana UniversityUniversity of South Florida; National Institute on Minority Health and Health... e altri collaboratoriCompletatoIntervento DECIDE modificato | Trattamento come consueto gruppo di curaStati Uniti
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access LivingAttivo, non reclutante
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VA Office of Research and DevelopmentRitiratoDisturbi del sonno e della veglia | Disturbi del sonno | Disturbi legati al sonnoStati Uniti