Exercise is Medicine: a Pilot Study
19. desember 2019 oppdatert av: Lee Kam Pui, Chinese University of Hong Kong
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Hong Kong, Hong Kong
- Lek Yuen Clinic
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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rate of retention
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinic blood pressure (BP)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
21. mai 2019
Primær fullføring (Faktiske)
1. september 2019
Studiet fullført (Faktiske)
1. desember 2019
Datoer for studieregistrering
Først innsendt
16. april 2019
Først innsendt som oppfylte QC-kriteriene
18. april 2019
Først lagt ut (Faktiske)
19. april 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. desember 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. desember 2019
Sist bekreftet
1. desember 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NTEC-2019-0121
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Will make available on personal requests to investigators
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