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

NCT05433233 | Completed

• 1 other identifier: 20-375-00
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Aging

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure

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

  20 weeks

Study Arms (2)

HAPA

EXPERIMENTAL

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

No HAPA

EXPERIMENTAL

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

Walking BEHAVIORAL

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

HAPA; No HAPA

HAPA Behavior Change Counseling OTHER

Structured dialogue for initiating behavior change.

HAPA

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50014, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Walking

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Duck-chul Lee, PhD

  Iowa State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: September 9, 2020
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: One year after publication
• Access Criteria: With a signed data use agreement with Iowa State University

Locations

US (1)