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出境医 / 临床实验 / Exercise is Medicine: a Pilot Study

Exercise is Medicine: a Pilot Study

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypertension Diabetes Mellitus Behavioral: EIM exercise classes and intervention Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise is Medicine for Chronic Diseases: a Pilot Study for Future Randomized Controlled Trial
Actual Study Start Date : May 21, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : December 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: 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
 Behavioral: EIM exercise classes and intervention
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.
Outcome Measures
Primary Outcome Measures :
  1. rate of retention [ Time Frame: from recruitment to finish of the 12-week program ]
    rate of retention

  2. Rate of recruitment [ Time Frame: from recruitment to the start of the 12-week program ]
    Rate of recruitment


Secondary Outcome Measures :
  1. Clinic blood pressure (BP) [ Time Frame: on recruitment and after the 12- week class ]
    Clinical BP will be measured 3 times and the last 2 will be averaged

  2. HbA1c (glycosylated hemoglobin) [ Time Frame: on recruitment and after the 12- week class ]
    for DM patients only

  3. Godin-Shephard Laiesure-Time Physical Activity Questoinnaire [ Time Frame: on recruitment and after the 12- week class ]
    a validated questionnaire to detect change in exercise level

  4. body mass index (BMI) [ Time Frame: on recruitment and after the 12- week class ]
    the weight and height of the patients will be measured

  5. body fat percentage [ Time Frame: on recruitment and after the 12- week class ]
    body fat percentage

  6. lipid level [ Time Frame: on recruitment and after the 12- week class ]
    this will include low-density lipoprotein, high-density lipoprotein, and total lipoprotein

  7. 9-item patient health questionnaire [ Time Frame: on recruitment and after the 12- week class ]
    a validated questionnaire to detect depressive symptoms

  8. Generalized anxiety disorder-7 [ Time Frame: on recruitment and after the 12- week class ]
    a validated questionnaire to detect anxiety symptoms

  9. EQ-5D-5L [ Time Frame: on recruitment and after the 12- week class ]
    a validated questionnaire to measure quality of life


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Hong Kong
Lek Yuen Clinic
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE May 21, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • rate of retention [ Time Frame: from recruitment to finish of the 12-week program ]
    rate of retention
  • Rate of recruitment [ Time Frame: from recruitment to the start of the 12-week program ]
    Rate of recruitment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Clinic blood pressure (BP) [ Time Frame: on recruitment and after the 12- week class ]
    Clinical BP will be measured 3 times and the last 2 will be averaged
  • HbA1c (glycosylated hemoglobin) [ Time Frame: on recruitment and after the 12- week class ]
    for DM patients only
  • Godin-Shephard Laiesure-Time Physical Activity Questoinnaire [ Time Frame: on recruitment and after the 12- week class ]
    a validated questionnaire to detect change in exercise level
  • body mass index (BMI) [ Time Frame: on recruitment and after the 12- week class ]
    the weight and height of the patients will be measured
  • body fat percentage [ Time Frame: on recruitment and after the 12- week class ]
    body fat percentage
  • lipid level [ Time Frame: on recruitment and after the 12- week class ]
    this will include low-density lipoprotein, high-density lipoprotein, and total lipoprotein
  • 9-item patient health questionnaire [ Time Frame: on recruitment and after the 12- week class ]
    a validated questionnaire to detect depressive symptoms
  • Generalized anxiety disorder-7 [ Time Frame: on recruitment and after the 12- week class ]
    a validated questionnaire to detect anxiety symptoms
  • EQ-5D-5L [ Time Frame: on recruitment and after the 12- week class ]
    a validated questionnaire to measure quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise is Medicine: a Pilot Study
Official Title  ICMJE Exercise is Medicine for Chronic Diseases: a Pilot Study for Future Randomized Controlled Trial
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
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
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Diabetes Mellitus
Intervention  ICMJE Behavioral: EIM exercise classes and intervention
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.
Study Arms  ICMJE Experimental: 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
Intervention: Behavioral: EIM exercise classes and intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2019) 		30
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2019) 		40
Actual Study Completion Date  ICMJE December 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922022
Other Study ID Numbers  ICMJE NTEC-2019-0121
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Will make available on personal requests to investigators
Responsible Party Lee Kam Pui, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese University of Hong Kong
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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