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Exercise is Medicine: a Pilot Study

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ClinicalTrials.gov Identifier: NCT03922022
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Lee Kam Pui, Chinese University of Hong Kong

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922022


Contacts
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Contact: Kam Pui Lee, MSc 2252 8562 lkp032@cuhk.edu.hk

Locations
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Hong Kong
Lek Yuen Clinic Recruiting
Hong Kong, Hong Kong
Contact: Kam Pui Lee, Msc    +852 60996560    Lkp032@cuhk.edu.hk   
Principal Investigator: Kam pui Lee, Msc         
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Lee Kam Pui, Clinical Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03922022     History of Changes
Other Study ID Numbers: NTEC-2019-0121
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will make available on personal requests to investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases