Exercise is Medicine: a Pilot Study
19 december 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
30
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
-
-
-
Hong Kong, Hongkong
- Lek Yuen Clinic
-
-
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:
- 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
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: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
rate of retention
Tijdsspanne: from recruitment to finish of the 12-week program
|
rate of retention
|
from recruitment to finish of the 12-week program
|
|
Rate of recruitment
Tijdsspanne: from recruitment to the start of the 12-week program
|
Rate of recruitment
|
from recruitment to the start of the 12-week program
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinic blood pressure (BP)
Tijdsspanne: on recruitment and after the 12- week class
|
Clinical BP will be measured 3 times and the last 2 will be averaged
|
on recruitment and after the 12- week class
|
|
HbA1c (glycosylated hemoglobin)
Tijdsspanne: on recruitment and after the 12- week class
|
for DM patients only
|
on recruitment and after the 12- week class
|
|
Godin-Shephard Laiesure-Time Physical Activity Questoinnaire
Tijdsspanne: on recruitment and after the 12- week class
|
a validated questionnaire to detect change in exercise level
|
on recruitment and after the 12- week class
|
|
body mass index (BMI)
Tijdsspanne: on recruitment and after the 12- week class
|
the weight and height of the patients will be measured
|
on recruitment and after the 12- week class
|
|
body fat percentage
Tijdsspanne: on recruitment and after the 12- week class
|
body fat percentage
|
on recruitment and after the 12- week class
|
|
lipid level
Tijdsspanne: on recruitment and after the 12- week class
|
this will include low-density lipoprotein, high-density lipoprotein, and total lipoprotein
|
on recruitment and after the 12- week class
|
|
9-item patient health questionnaire
Tijdsspanne: on recruitment and after the 12- week class
|
a validated questionnaire to detect depressive symptoms
|
on recruitment and after the 12- week class
|
|
Generalized anxiety disorder-7
Tijdsspanne: on recruitment and after the 12- week class
|
a validated questionnaire to detect anxiety symptoms
|
on recruitment and after the 12- week class
|
|
EQ-5D-5L
Tijdsspanne: on recruitment and after the 12- week class
|
a validated questionnaire to measure quality of life
|
on recruitment and after the 12- week class
|
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 (Werkelijk)
21 mei 2019
Primaire voltooiing (Werkelijk)
1 september 2019
Studie voltooiing (Werkelijk)
1 december 2019
Studieregistratiedata
Eerst ingediend
16 april 2019
Eerst ingediend dat voldeed aan de QC-criteria
18 april 2019
Eerst geplaatst (Werkelijk)
19 april 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 december 2019
Laatste update ingediend die voldeed aan QC-criteria
19 december 2019
Laatst geverifieerd
1 december 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NTEC-2019-0121
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Beschrijving IPD-plan
Will make available on personal requests to investigators
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .