Walking and Blood Pressure in Older Adults With Respiratory Impairment.

NCT ID: NCT06033417

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-05-31

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.

Detailed Description

Older adults are particularly susceptible to respiratory impairment (a condition of lung dysfunction) due in part to longer lifetime exposures to air pollutants, tobacco smoke, and physical inactivity. Older adults with respiratory impairment have greater long-term risks of death by cardiovascular disease (CVD) when compared to individuals without respiratory impairment. Impaired lung function tends to run parallel with high blood pressure, and high blood pressure is a determinant of CVD mortality in this population. One approach to lowering blood pressure across the lifespan is by increasing physical activity (PA) behavior. Walking is the most commonly practiced modality of PA in older adulthood, and previous studies show that accumulating an additional 3,000 steps/day over 5-days a week through activities of daily living (i.e., 'lifestyle stepping') reduces blood pressure in inactive older adults free from respiratory impairment. This step-based PA prescription roughly equates to 150-minutes of moderate-intensity aerobic PA/week for most inactive older adults, and therefore satisfies the minimum aerobic PA recommendations for substantial health benefits. However, the impact of such an intervention on blood pressure in older adults with respiratory impairment is unclear. The 'Physical Activity Guidelines for Americans: Midcourse Report' (2023) indicates that senior centers are key settings for successful PA interventions. Senior-living communities are traditionally well-designed and well-resourced to support PA (e.g., safe outdoor walking spaces; access to indoor exercise facilities; social support, etc.), making them highly suitable locations for lifestyle walking. Additionally, the prescription of PA using lifestyle step counts rather than time-based prescriptions is intuitive and arguably easier to integrate into activities of daily living. However, no study has yet evaluated the effect of increasing daily lifestyle step counts on blood pressure in older adults with respiratory impairment. Addressing this gap in knowledge will provide support for the utility of lifestyle walking as a therapeutic approach to CVD risk management in older adults with lung dysfunction.

Conditions

Respiratory Impairment; Elevated Blood Pressure; Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Increased lifestyle walking (intervention)

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

Group Type: EXPERIMENTAL

Increased lifestyle walking (intervention)

Intervention Type: 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.

Health education only (control)

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).

Group Type: OTHER

Health education only (control)

Intervention Type: 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.

Interventions

Increased lifestyle walking (intervention)

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.

Intervention Type: OTHER

Health education only (control)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iowa State University

OTHER

Sponsor Role: lead

Responsible Party

Duck-chul Lee

Professor, Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duck-chul Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Iowa State University

Locations

Iowa State University

Ames, Iowa, United States

Countries

United States

Other Identifiers

23-200-00

Identifier Type: -

Identifier Source: org_study_id