Plain English Summary
Background and study aims
More than 50% of senior Chinese suffer from hypertension (high blood pressure) and this number is growing along with the rapid economic growth in China. Therefore, the prevention of high blood pressure related consequences, particularly heart attack and stroke, becomes a number one priority for chronic disease prevention. To control high blood pressure, the Wuhan Center for Disease Prevention and Control established the Community-Based Hypertension Control Program (CBHCP) in 2006 to deliver a drug-treatment program. This strategy emphasizes drug treatment to low blood pressure without considering physical activity. Scientific evidence from diverse sources indicates that physical activity can be a promising and cost-effective measure for blood pressure control to reduce many life-threatening consequences, including heart attack and stroke. Based on a community-based program, this study is devised to test the effectiveness of a physical activity training program, ‘Keep Moving Toward Healthy Heart and Healthy Brain’ (KM2H2), in controlling high blood pressure and reducing risk for heart attack and stroke. To ensure feasibility and sustainability, the study focuses on the physical activities commonly practiced by old people in China, including jogging, quick walking, slow running, group-dancing and cycling.
Who can participate?
Patients aged 55 and over diagnosed by a doctor as hypertensive, currently on hypertensive medication, and able to safely participate in moderate or higher levels of physical activity.
What does the study involve?
Participants are randomly assigned to receive either KM2H2 or the standard CBHCP care. Participants will attend two lectures at community health centers regarding high blood pressure and its consequences, with emphasis on physical activities as an important approach for prevention. After the two lectures, participants will be followed-up twice. The first follow-up, a week after the lecture, is a one-on-on psychological counseling session to encourage safe and appropriate physical activities and to solve issues confronted in engaging in physical activities. One week later, the participants are followed up again through a researcher-guided small group session (8-10 patients) to exchange skills and experience in physical activities for blood pressure control and to foster social and emotional support among the participants. The counseling and small group sessions are repeated one month later to end the intervention. Boosters are arranged at three months post-intervention delivered also through one-on-one counseling and small group activities. During the course of the study, participants are asked to complete three surveys, one before the intervention and two at 3 and 6 months after the intervention. During each of these surveys, participants are interviewed by trained investigators regarding their medical conditions and physical activities. Participants will also provide blood samples to measure blood sugar and fat and blood pressure will be measured.
What are the possible benefits and risks of participating?
Participants may benefit from participating in the study in several ways. They may build a good habit for exercise, they main gain better control of their high blood pressure, and they may also reduce the risk of heart attack and stroke. No significant risk is anticipated with the safety measures for physical activities as the research study emphasized. In case an accident happens because of participation in this study, participants are warranted priority to access care at all levels from the local community health centers to the tertiary level hospitals in Wuhan.
Where is the study run from?
Wuhan Center for Disease Prevention and Control (China).
When is the study starting and how long is it expected to run for?
April 2011 to November 2011
Who is funding the study?
Wuhan Centers for Disease Prevention and Control and Hong Kong Polytechnic University (China)
Who is the main contact?
Dr Jie Gong
Dr Xinguang Chen
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jie Gong
ORCID ID
Contact details
24 N. Jiang-Han-Bei-Lu Road
Wuhan
430022
China
Type
Scientific
Additional contact
Dr Xinguang Chen
ORCID ID
http://orcid.org/0000-0001-8263-643X
Contact details
2004 Mowry Rood
Gainesville
32610
United States of America
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A physical activity enhancement program KM2H2 for secondary prevention of hypertension among old adults
Acronym
KM2H2
Study hypothesis
Senior hypertensive patients can be motivated to participate in physical activity and a moderate level of physical activity has a significant effect to reduce the life-threatening consequences of hypertension, particularly the incidence of heart attack and stroke.
Ethics approval
1. University of Florida IRB, 07/14/2014, ref: IRB201400518
2. Wuhan CDC, 03/15/2010, ref: WHN.IRB30124
3. Hong Kong Polytech, 08/26/2010, ref: HKT_IRB2010C1032
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Hypertension
Intervention
The study participants (n=450) from 12 community health centers were randomly assigned to receive either KM2H2 (n=232) or the standard care (n=218).
The KM2H2 intervention include six sessions, plus two booster sessions. The first session covers basic knowledge about hypertension and motivation of physical activity, the second session is for physical activity training, the third session is one-on-one counseling, and the fourth session is small group activity. These four sessions are delivered on a weekly basis. Sessions three and four are repeated once to complete the intervention. The intervention program is based on a extended Transtheoritical Model to incorporate the Model of Personalized Medicne for individualized counseling and the Social Capital Theory for small group activities.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Levels of physical activity measured using the a verified survey questionnaire
2. Incidence of heart attack and stroke determined with medical records
2. Blood pressure assessed following the standard protocol of the American Hypertension Association
Measured at baseline and the two follow-ups 3 months and 6 months post-intervention
Secondary outcome measures
Blood fats and sugar (total cholesterol, HDL, LDL) were measured using the standard methods at the Biochemistry Laboratory at Wuhan CDC at baseline and the two follow-ups 3 months and 6 months post-intervention
Overall trial start date
20/04/2011
Overall trial end date
28/11/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 55 and above
2. Diagnosed by a doctor as hypertensive (SBP greater or equal 140 mmHg and DBP greater or equal 90 mmHg)
3. Currently on hypertensive medication
4. Able to participate in moderate or higher levels of physical activity safely
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
450
Participant exclusion criteria
1. Significant physical and other medical conditions preventing from participating in physical activities
2. Failure in physical activity safety screen test
2. Obvious EKG abnormalities
Recruitment start date
20/04/2011
Recruitment end date
08/06/2011
Locations
Countries of recruitment
China
Trial participating centre
Wuhan Center for Disease Prevention and Control
24 Jiang-Han-Bei-Lu Road
Wuhan
430022
China
Funders
Funder type
University/education
Funder name
Wuhan Centers for Disease Prevention and Control
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Hong Kong Polytechnic University
Alternative name(s)
Hong Kong PolyU, PolyU
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Hong Kong
Results and Publications
Publication and dissemination plan
Publish the study findings, apply for new funding for phase 3 trial.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26426421
2018 30-month results in: http://www.ncbi.nlm.nih.gov/pubmed/29291739