Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01280903
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2010-12-17
Brief Title:
Staying Active With Arthritis RCT of Physical Activity for Older Adults With Osteoarthritis and Hypertension
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Promoting Physical Activity in Older Adults With Comorbidity
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
The purpose of the Staying Active with Arthritis STAR research study is to determine if a 6-month program will improve leg exercise fitness walking and clinical outcomes function blood pressure leg strength pain fatigue and health-related quality of life in older adults with osteoarthritis of the knee and high blood pressure
Detailed Description:
Over 9 million Americans have symptomatic osteoarthritis OA of the knee a chronic disease associated with frequent joint pain functional limitations and quadriceps weakness that intrude upon everyday life At least half of those with OA of the knee are diagnosed with hypertension or high blood pressure HBP one of the most prevalent risk factors for cardiovascular disease Many other individuals with OA of the knee unknowingly have HBP and remain untreated Our own work and that of others suggest that persons with OA of the knee experience reductions in BP when they participate in a regular regimen of physical activity Even small decreases in systolic and diastolic BP found with physical activity are clinically significant eg a 2 mm Hg decrease reduces the risk of stroke by 14 - 17 and the risk of coronary heart disease is reduced by 6 - 9 Yet only 15 of persons with OA and 47 with HBP engage in regular physical activity The purpose of this study is to investigate how the individually delivered home-based 6-month modified Staying Active with Arthritis STAR intervention guided by self-efficacy theory and modified to address comorbid HBP affects lower extremity exercise flexibility strengthening and balance fitness walking functional status BP quadriceps strength pain fatigue and health-related quality of life HRQoL in a convenience sample of 224 adults age 50 years or older with OA of the knee and HBP Using a randomized controlled 2-group design we 1 hypothesize that at the end of the 6-month intervention period and 6 months after the intervention period ends those who receive the modified STAR intervention will be more likely to perform lower extremity exercise participate in fitness walking show improvements in objective functional status and demonstrate reductions in BP than those who receive attention-control Secondarily we will 2 evaluate the impact of the modified STAR intervention compared to attention-control on subjective functional status quadriceps strength pain fatigue and HRQoL at both time points 3 explore the impact of the modified STAR intervention compared to attention-control on self-efficacy and outcome expectancy at both time points 4 explore the relationship between self-efficacy and outcome expectancy and 5 explore the extent to which self-efficacy and outcome expectancy mediate the relationship between the modified STAR intervention and performance of lower extremity exercise and participation in fitness walking Data will be analyzed using repeated measures modeling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NR010904-01A1 | NIH | None | httpsreporternihgovquickSearchR01NR010904-01A1 |