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

Sponsor
Iowa State University (Other)
Overall Status
Completed
CT.gov ID
NCT05433233
Collaborator
(none)
21
1
2
6.4
3.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Walking
  • Other: HAPA Behavior Change Counseling
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
Actual Study Start Date :
Sep 9, 2020
Actual Primary Completion Date :
Mar 22, 2021
Actual Study Completion Date :
Mar 22, 2021

Arms and Interventions

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

Other: HAPA Behavior Change Counseling
Structured dialogue for initiating behavior change.

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

Outcome Measures

Primary Outcome Measures

  1. Change in blood pressure [20 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Iowa State University Ames Iowa United States 50014

Sponsors and Collaborators

  • Iowa State University

Investigators

  • Principal Investigator: Duck-chul Lee, PhD, Iowa State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duck-chul Lee, Professor, Iowa State University
ClinicalTrials.gov Identifier:
NCT05433233
Other Study ID Numbers:
  • 20-375-00
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022