Walking and Blood Pressure in Older Adults With Respiratory Impairment.

NCT06033417 | Unknown

• 1 other identifier: 23-200-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of an 8-week walking program on blood pressure in inactive older adults with respiratory impairment, a condition where lung function is sub-optimal for a person's age. Older adults with respiratory impairment have greater risks of death by cardiovascular disease (CVD) compared to those without respiratory impairment, and this may be partly driven by higher resting blood pressure. One way to lower blood pressure is to increase the number of daily steps achieved throughout the course of everyday life ('lifestyle steps'), and previous research shows that an additional 3,000 lifestyle steps/day is effective for achieving this. However, whether an increase in daily lifestyle steps is effective for reducing blood pressure in senior-community dwelling older adults with respiratory impairment is unknown. Understanding how increasing daily steps impacts blood pressure in this understudied population is important for informing future strategies for tackling cardiovascular disease risk in those with lung dysfunction.

Conditions

Respiratory Impairment; Elevated Blood Pressure; Physical Inactivity

Keywords

Physical activity; Step counts; Lung function; Blood pressure; Older adults; Walking

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure

  Pre- and post-intervention brachial blood pressure (upper left arm) will be assessed after 10-minutes of quiet rest in the supine position using the SphygmoCor device (AtCor Medical, Itasca, IL, USA), an automated blood pressure monitor. The participant will be free of constrictive clothing, their legs will be uncrossed, and their back will be supported by a cushioned surface (i.e., bed) beneath them. A minimum of 3 blood pressure measurements will be taken at intervals of at least 2 minutes.

  0-weeks, 8-weeks

Secondary Outcomes (1)

• Feasibility of conducting the study

  8-weeks

Other Outcomes (11)

• Change in arterial stiffness

  0-weeks, 8-weeks

• Change in lung function

  0-weeks, 8-weeks

• Change in SPPB performance

  0-weeks, 8-weeks

Study Arms (2)

Increased lifestyle walking (intervention)

EXPERIMENTAL

Intentional increase in daily steps: 3,000 extra steps/day, 5-days a week, 8-weeks total.

Other: Increased lifestyle walking (intervention)

Health education only (control)

OTHER

Health education and no intentional increase in baseline daily steps (but with the option to receive the intervention upon conclusion of the initial 8-weeks).

Other: Health education only (control)

Interventions

Increased lifestyle walking (intervention) OTHER

Participants will increase their baseline steps by a minimum of 3,000 extra steps/day, 5-days/week, for 8-weeks. Baseline steps will be assessed using a pedometer over a 7-day period before the intervention, after which a new (higher) daily step target will be assigned. The intervention will take place in the free-living setting, with participants reaching their step goals by engaging in more activities of daily living or via purposeful physical activity. Participants will wear a pedometer throughout the 8-week period to keep track of their steps, and adherence to the protocol will be determined by collecting the stored step data directly from each participant's pedometer on a weekly basis. Participants will be supported in their efforts to meet their daily step targets by engaging in once-weekly walking groups (30-mins/session) led by research staff. They will also receive 20-minute phone calls once every two weeks to set goals and create action plans for reaching their step targets.

Increased lifestyle walking (intervention)

Health education only (control) OTHER

Those randomized to the delayed participation group will be instructed to maintain their 'normal' lifestyle activities, thereby avoiding any significant increase in daily step counts beyond their 'baseline' values. Participants will wear a pedometer throughout the 8-week period to keep track of their steps, and adherence to the protocol will be determined by collecting the stored step data directly from each participant's pedometer on a weekly basis. Participants in this group will attend once-weekly group health education sessions (30-minutes/session), in addition to 5-minute, 'touch base' phone calls once every 2-weeks, but these phone calls will not involve goal-setting or action planning. After completing the initial 8-week period, these individuals can then opt to undertake the 'increased lifestyle walking' intervention of 3,000 extra steps/day over 5-days for 8-weeks if desired.

Health education only (control)

Eligibility Criteria

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

You may qualify if:

• Men and women aged 65 years and above.
• Elevated systolic blood pressure (120mmHg - 159 mmHg), and/or individuals taking medications for high blood pressure with a systolic pressure less than or equal to 159mmHg.
• Respiratory impairment as assessed by abnormal spirometry (a lung function test). Abnormal spirometric phenotypes include obstructive pattern, restrictive pattern, mixed obstructive/restrictive, and preserved ratio impaired spirometry (PRISm).
• Non-smoker (defined as being tobacco-free for at least the previous 12-months).
• Body mass index (BMI) \<42kg/m2.
• Physically inactive (determined by a 7-day day assessment of step counts using a pedometer, and defined as having an average daily step count \<7,000).
• Willingness to increase daily steps.

You may not qualify if:

• History of stroke, heart attack, or cancer diagnosis in the last 6-months.
• Admission to hospital for a respiratory-related illness (e.g., COPD exacerbation, pneumonia, lung injury, etc.) within the last 3 months.
• The use of supplemental oxygen.
• Neurological conditions such as Alzheimer's or Parkinson's disease.
• Significant mobility limitation (e.g., severe arthritis) that would hinder the ability to increase daily steps.
• The use of a cane or walker.
• Participants engaged in another walking study or structured walking program.

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Hypertension; Sedentary Behavior; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Duck-chul Lee, PhD

  Iowa State University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available for sharing from January 2024 onward, and pre-analysis plans can be submitted indefinitely thereafter.
• Access Criteria: There are no data-sharing agreements in place at this time. However, the study has IRB support to share data in a manner that maintains the confidentiality of participants, honors assurances made to participants during informed consent, and complies with data privacy regulations. Researchers wishing to affiliate with the project must first pass a course on the Protection of Human Subjects, and data requests will be conveyed to the institutional review board (IRB) (if required). The IRB will determine the nature of the request and later provide recommendations. Approval will be based on a pre-submitted analysis plan from the researchers. Upon approval, an agreement between the PI and the researchers will be made, and de-identified data will be cut from the main dataset and distributed electronically. The researchers will agree to publish only the results of the analysis plan, and must seek further assent if significant deviations from this plan are made.

Locations

US (1)