Physical Inactivity Clinical Trial
Official title:
The Effect of an 8-week Walking Intervention on Blood Pressure in Older Adults With Respiratory Impairment: A Pilot Study.
Verified date | September 2023 |
Source | Iowa State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | May 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Iowa State University | Ames | Iowa |
Lead Sponsor | Collaborator |
---|---|
Iowa State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in arterial stiffness | Pre- and post-intervention arterial stiffness will be estimated through the assessment of carotid-femoral pulse wave velocity using the SphygmoCor device (AtCor Medical, Itasca, IL, USA) immediately following the resting blood pressure assessment. The participant will lie down and a blood pressure cuff will be placed around the upper leg and a pressure sensor will be applied to the carotid artery to obtain femoral and carotid pulse waves. The distance between the femoral and carotid pulses will be measured with a tape measure and the pulse transit time between the two locations will be calculated by the SphygmoCor device (AtCor Medical, Itasca, IL, USA). | 0-weeks, 8-weeks | |
Other | Change in lung function | Pre- and post-intervention lung function will be assessed by spirometry using a handheld spirometer (EasyOne Air, NDD Medical Technologies, Andover, MA), specifically performing the Forced Vital Capacity (FVC) maneuver. The participant begins by inhaling air to maximum lung volume without the device in their mouth, and then forcefully exhaling through the device until the lungs are completely emptied. A minimum of 3 and a maximum of 8 FVC maneuvers will be will be performed following the American Thoracic Society guidelines, and the device will use inbuilt algorithms to measure the forced expiratory time. The primary indices of lung function will include the Forced Vital Capacity (FVC), the Forced Expiratory Volume in 1-second (FEV1), and the ratio between the two (FEV1/FVC). | 0-weeks, 8-weeks | |
Other | Change in SPPB performance | Pre- and post-intervention assessment of lower extremity functioning consists of a usual-paced walking test (i.e., normal gait speed) over a flat 4m course; a series of two-footed balance poses each lasting 10 seconds: feet side-by-side, feet partially staggered [semi-tandem], and feet in the heel-to-toe position [fully tandem]; and five unaided chair stands completed as quickly as possible. | 0-weeks, 8-weeks | |
Other | Change in functional capacity | Pre- and post-intervention functional capacity will be evaluated using the fast 400m walk test, a validated measure of walking ability and endurance designed specifically for older adults. Participants will walk at a fast pace around two cones set 20m apart in a long hallway on level ground for 10 full laps (i.e., 400m), and the time taken to complete the test (mins:secs) will be recorded (faster times equate to better functional capacity). Participants will be provided with verbal encouragement throughout to test to maximize the effort exerted. | 0-weeks, 8-weeks | |
Other | Change in exertional dyspnea (breathlessness) | Pre- and post-intervention exertional dyspnea (the perception of breathlessness experienced during exercise) will be assessed using a validated 10-level severity scale (modified Borg index) where 0 = no shortness of breath and 10 = maximum shortness of breath. The Borg index will be administered immediately following completion of the functional capacity test (i.e., fast 400m walk). | 0-weeks, 8-weeks | |
Other | Change in sleep quality | Pre- and post-intervention sleep quality will be evaluated using the validated Pittsburgh Sleep Quality Index (PSQI). | 0-weeks, 8-weeks | |
Other | Change in quality of life | Pre- and post-intervention quality of life will be evaluated using the validated 36-item short form survey (SF-36). | 0-weeks, 8-weeks | |
Other | Change in respiratory symptoms | Pre- and post-intervention respiratory symptoms will be evaluated using the validated St. George's Respiratory Questionnaire (SGRQ). | 0-weeks, 8-weeks | |
Other | Change in fatigability | Pre- and post-intervention physical and mental fatigability will be evaluated using the validated Pittsburgh Fatigability Scale. This is a 10-item questionnaire that evaluates self-reported whole-body physical and mental tiredness anchored to activities of fixed intensity and duration in adults age =60 years. Each item in the scale ranges from 0 to 5, where 0 represents "no fatigue whatsoever" and 5 represents "extreme fatigue." The scores from each item are then summed to give a total score between 0 and 50. A higher score reflects greater fatigability. | 0-weeks, 8-weeks | |
Other | Change in cognitive performance | Pre- and post intervention cognitive performance will be evaluated using the validated modified mini-mental state examination (3MS). | 0-weeks, 8-weeks | |
Other | Change in waist circumference | Pre- and post intervention waist circumference (measured in cm) will be evaluated using a digital measuring tape (Smart Tape Measure V001, Fitindex, Eastvale, CA). | 0-weeks, 8-weeks | |
Primary | 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 | 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. | 8-weeks |
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