ClinicalTrials.gg
CompletedNCT05433233Updated Jun 30, 2022

Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension

An interventional study of Walking and HAPA Behavior Change Counseling in Hypertension and Aging, sponsored by Iowa State University. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-06-30.

Sponsored by Iowa State University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Sep 2020, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Hypertension
  • Aging

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03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 21 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Iowa State University is the lead sponsor of 37 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    HAPA

    Participants assigned additional 3,000 steps/day on 5 days/week. Participants also received an additional 15 minutes of structured conversation with research personnel following the Health Action Process Approach Theory for behavior change.

    Behavioral: Walking · Other: HAPA Behavior Change Counseling

  • Experimental
    No HAPA

    Participants assigned additional 3,000 steps/day on 5 days/week and general conversation with researchers in regard to behavior change, not following a structured dialogue.

    Behavioral: Walking

Interventions

  • BehavioralWalking

    Participants will perform 3,000 additional steps/day on 5 days/week.

  • OtherHAPA Behavior Change Counseling

    Structured dialogue for initiating behavior change.

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What researchers measure

Primary outcomes

  1. Change in blood pressure

    The primary outcome is the change in measured systolic and diastolic blood pressure from baseline.

    Time frame: 20 weeks

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Study locations

1 site
  • Iowa State University
    Ames, Iowa 50014, United States
08

References and documents

Individual participant data

Plan to share: Yes — Request for sharing de-identified data should be addressed to the Principal Investigator: Duck-chul Lee at dclee@iastate.edu

Supporting information: Statistical analysis plan, Informed consent form

Time frame: One year after publication

Access criteria: With a signed data use agreement with Iowa State University

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05433233
Lead sponsor
Iowa State University
Responsible party
Duck-chul Lee (Professor, Iowa State University) — Principal investigator
First posted
Jun 27, 2022
Start date
Sep 9, 2020
Primary completion
Mar 22, 2021
Completion
Mar 22, 2021
Last update
Jun 30, 2022

Study contacts

Duck-chul Lee, PhD
principal investigator · Iowa State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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