Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106327
Status:
COMPLETED
Last Update Posted:
2012-07-25
First Post:
2005-03-22
Brief Title:
Improving Functioning in Peripheral Arterial Disease
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Improving Functioning in Peripheral Arterial Disease
Status:
COMPLETED
Status Verified Date:
2012-07
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:
None
Brief Summary:
The purpose of this study is to compare the effects of nutrition a supervised treadmill exercise program and supervised progressive resistance training program on peripheral arterial disease
Detailed Description:
BACKGROUND
Previous work demonstrates that functional limitations associated with peripheral arterial disease PAD are diverse and include slower walking speed poorer walking endurance and impaired balance as compared to persons without PAD Although treadmill-walking exercise improves treadmill performance in patients with intermittent claudication IC treadmill performance does not correlate well with community walking ability in older men and women In older patient populations without PAD resistance training improves functioning and walking endurance but this mode of exercise has not been sufficiently studied in PAD Furthermore although 65 to 70 of men and women with PAD are either asymptomatic or have exertional leg symptoms other than IC no prior studies have assessed the effects of exercise interventions in PAD patients who do not have IC
DESIGN NARRATIVE
The randomized control study will determine whether a 6-month supervised treadmill exercise program and a supervised lower extremity progressive resistance training program respectively improve lower extremity functioning compared to a nutrition control group among 150 PAD patients with and without IC The investigators hypothesize that participants in the treadmill walking exercise program and participants in the progressive resistance training program respectively will experience greater improvement in functional outcomes than participants in the nutrition control group The primary functional outcome measures in descending order of importance are 6-minute walk distance and the summary performance score The summary performance score is a composite measure of lower extremity functioning usual walking speed standing balance and time required for five repeated chair rises measured on a 0-12 scale that predicts future risk of nursing home placement mobility loss and mortality The study will also identify mechanisms by which the exercise interventions improve functioning in PAD Mechanisms to be studied include changes in blood viscosity calf blood flow brachial artery endothelial reactivity and inflammatory cytokine levels By identifying the optimal exercise program for improving functioning in PAD patients with and without IC the findings will have substantial clinical and public health implications for millions of patients with PAD
Previous work demonstrates that functional limitations associated with peripheral arterial disease PAD are diverse and include slower walking speed poorer walking endurance and impaired balance as compared to persons without PAD Although treadmill-walking exercise improves treadmill performance in patients with intermittent claudication IC treadmill performance does not correlate well with community walking ability in older men and women In older patient populations without PAD resistance training improves functioning and walking endurance but this mode of exercise has not been sufficiently studied in PAD Furthermore although 65 to 70 of men and women with PAD are either asymptomatic or have exertional leg symptoms other than IC no prior studies have assessed the effects of exercise interventions in PAD patients who do not have IC
DESIGN NARRATIVE
The randomized control study will determine whether a 6-month supervised treadmill exercise program and a supervised lower extremity progressive resistance training program respectively improve lower extremity functioning compared to a nutrition control group among 150 PAD patients with and without IC The investigators hypothesize that participants in the treadmill walking exercise program and participants in the progressive resistance training program respectively will experience greater improvement in functional outcomes than participants in the nutrition control group The primary functional outcome measures in descending order of importance are 6-minute walk distance and the summary performance score The summary performance score is a composite measure of lower extremity functioning usual walking speed standing balance and time required for five repeated chair rises measured on a 0-12 scale that predicts future risk of nursing home placement mobility loss and mortality The study will also identify mechanisms by which the exercise interventions improve functioning in PAD Mechanisms to be studied include changes in blood viscosity calf blood flow brachial artery endothelial reactivity and inflammatory cytokine levels By identifying the optimal exercise program for improving functioning in PAD patients with and without IC the findings will have substantial clinical and public health implications for millions of patients with PAD
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 |
|---|---|---|---|
| R01HL073351 | NIH | None | httpsreporternihgovquickSearchR01HL073351 |