Respiratory ImpairmentNCT06033417
Walking and Blood Pressure in Older Adults With Respiratory Impairment.
A study testing Increased lifestyle walking (intervention) in people with Respiratory Impairment and Elevated Blood Pressure, run by Iowa State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Respiratory Impairment, Elevated Blood Pressure, Physical Inactivity
- What is being tested?
- Increased lifestyle walking (intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an 8-week Walking Intervention on Blood Pressure in Older Adults With Respiratory Impairment: A Pilot Study.
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.
Read the 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.
- Being tested
- Increased lifestyle walking (intervention), Health education only (control)
- Keywords
- Physical activity, Step counts, Lung function, Blood pressure, Older adults, Walking
- Medical subject headings
- Respiratory Insufficiency, Hypertension, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Increased lifestyle walking (intervention) | Experimental | Intentional increase in daily steps: 3,000 extra steps/day, 5-days a week, 8-weeks total. Receives: 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). Receives: Other: Health education only (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-weeks, 8-weeks
Secondary outcomes (1)
Feasibility of conducting the study
The secondary purpose of this pilot study is to explore two (2) facets of feasibility: adherence and attrition, with the study considered to be feasible if 'high adherence' and 'low attrition' are observed. High adherence is defined as all participants meeting their daily step goals 80% of the time (i.e., 32 days out of a possible 40 days). Low attrition is defined as 80% or more participants attending both pre- and post-intervention assessments.
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duck-chul Lee, Iowa State University
- Investigators
- Duck-chul Lee, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033417
- Sponsor's protocol ID
- 23-200-00
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, individual participant data may be shared with researchers outside of the institution upon submission of a pre-analysis plan and, if required by federal regulations, approval from the institutional review board (IRB).
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an 8-week Walking Intervention on Blood Pressure in Older Adults With Respiratory Impairment: A Pilot Study.
- ClinicalTrials.gov ID
- NCT06033417
- Acronym / sponsor ID
- 23-200-00
- Keywords
- Physical activity, Step counts, Lung function, Blood pressure, Older adults, Walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increased lifestyle walking (intervention) | Experimental | Other: Increased lifestyle walking (intervention)Intentional increase in daily steps: 3,000 extra steps/day, 5-days a week, 8-weeks total. |
| Health education only (control) | Other | Other: 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Increased lifestyle walking (intervention) |
| 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. | Other | Health education only (control) |
Primary outcome
Change in systolic blood pressure
Time frame: 0-weeks, 8-weeks
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.
1 secondary outcome
Feasibility of conducting the study
Time frame: 8-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Yes. De-identified, individual participant data may be shared with researchers outside of the institution upon submission of a pre-analysis plan and, if required by federal regulations, approval from the institutional review board (IRB).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duck-chul Lee, PhD principal investigator
Iowa State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased lifestyle walking (intervention) in people with Respiratory Impairment and Elevated Blood Pressure, run by Iowa State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: 0-weeks, 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.