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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05433233
Other study ID # 20-375-00
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2020
Est. completion date March 22, 2021

Study information

Verified date June 2022
Source Iowa State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Eight out of ten older adults have hypertension in the US, which is a strong risk factor for cardiovascular events. To manage hypertension, regular and structured exercise is effective and strongly recommended regardless of drug therapy. However, structured exercise is often performed in a health club, could be difficult, and warrants caution in older adults with chronic conditions. In contrast, the most common lifestyle physical activity in older adults is walking, which is inexpensive, easy, and safe. Recent technological advancement in activity monitoring provides reliable step counts and promotes lifestyle walking. Although one of the most popular public health goals is walking 10,000 steps/day, recent studies found that it is unrealistic and difficult to achieve. Further, there is very little evidence whether walking 10,000 steps/day is effective, specifically in older adults with hypertension. Walking 3,000 extra steps/day 5 days/week is equivalent to meeting the current aerobic physical activity guidelines, as it takes about 30 minutes each day, and is more realistic and achievable. Steps/day is easy to understand and captures most physical activities in older adults. However, there are no specific guidelines about how many daily steps are needed for older adults in the current physical activity guidelines. Thus, this project is aimed to provide pilot data to answer a simple, but unknown, question about physical activity in older adults: "Can increasing lifestyle walking in older adults with hypertension reduce blood pressure? And can older adults maintain a lifestyle walking intervention on their own?". This project will significantly contribute to developing more effective and easy physical activity guidelines for older adults.


Description:

All participants will be prescribed a step goal to increase their walking by 3,000 steps/day on 5 days/week for 20 weeks. During the first 10 weeks, support will be provided by research personnel to actively help obtain these goals. During weeks 11-20, participants will be in a self-maintenance phase where no research personnel assistance will be provided to help maintain the extra walking. Participants will log their steps every day during the 20-weeks from a pedometer that they will wear daily. Participants will assess blood pressure and weight at baseline, 10 and 20 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date March 22, 2021
Est. primary completion date March 22, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Men and women aged 65+ - Systolic/diastolic blood pressure of 130-159/80-99 mmHg. Participants will be allowed to be on blood pressure medication. - Body mass index of 25-40 kg/m2 - Non-smokers - Sedentary/inactive individuals: not meeting the current aerobic physical activity guidelines of 150 minutes per week over the past 3 months - Baseline average daily step count <8,000 steps Exclusion Criteria: - Any significant mobility limitation because our intervention requires an increase in 3,000 steps per day, which needs to be achievable by the participant. - A stroke, myocardial infarction (heart attack) or cancer diagnosis within the last 6 months.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Walking
Participants will perform 3,000 additional steps/day on 5 days/week.
Other:
HAPA Behavior Change Counseling
Structured dialogue for initiating behavior change.

Locations

Country Name City State
United States Iowa State University Ames Iowa

Sponsors (1)

Lead Sponsor Collaborator
Iowa State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in blood pressure The primary outcome is the change in measured systolic and diastolic blood pressure from baseline. 20 weeks
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