Ischemic Preconditioning Claudication Study
Paraules clau
Resum
Descripció
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication. Peripheral arterial disease (PAD) is a circulatory condition in which large supply blood vessels narrow, reducing oxygen and nutrient distribution to peripheral tissues. IPC protects against tissue damage caused by ischemia and can improve functional capacity in patients recovering from stroke; however, the benefit of ischemic preconditioning in patients with peripheral arterial disease remains unclear.
The investigators predict that ischemic preconditioning (IPC) will delay claudication onset time (COT), increase peak walking time (PWT) and improve muscle strength in patients with intermittent claudication.
The investigators will determine whether IPC improves claudication onset time (COT) and peak walking time (PWT) in patients with intermittent claudication. A motorized treadmill will be employed to assess COT and PWT.
The investigators will determine whether IPC can improve muscle strength and time to pain onset in the affected leg of patients with intermittent claudication. These metrics will be assessed quantitatively using a Biodex™ dynamometer.
Dates
| Darrera verificació: | 12/31/2019 |
| Primer enviat: | 04/08/2018 |
| Inscripció estimada enviada: | 04/17/2018 |
| Publicat per primera vegada: | 04/26/2018 |
| Última actualització enviada: | 01/19/2020 |
| Publicació de l'última actualització: | 01/21/2020 |
| Data d'inici de l'estudi real: | 06/13/2018 |
| Data estimada de finalització primària: | 12/30/2020 |
| Data estimada de finalització de l’estudi: | 12/30/2020 |
Condició o malaltia
Intervenció / tractament
Other: Ischemic Preconditioning
Other: Control
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Ischemic Preconditioning A standard blood pressure cuff will be placed on the right or left thigh, depending on the affected side, to occlude blood flow. The cuff will be inflated to 225 mmHg to prevent blood flow. Each session will consist of 4 cycles of 5 minute IPC applications, followed by 5 minutes of reperfusion for a total of 35 minutes. | Other: Ischemic Preconditioning See Ischemic Preconditioning Experimental group description |
| Sham Comparator: Control The sham intervention protocol will be identical to the IPC protocol except blood flow to the affected leg is unchanged as cuff pressure will be raised to between the venous and diastolic pressures | Other: Control See Control group description |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: 1. between ages of 18-80 2. able to give informed consent 3. presence of vascular disease with intermittent claudication Exclusion Criteria: 1. age < 18 or >80 2. unable to give informed consent 3. presence of vascular disease with leg pain at rest, ischemic ulceration, or gangrene 4. pregnancy 5. unable to walk on a treadmill 6. unable to perform or tolerate ischemic preconditioning 7. unable to follow commands 8. exercise capacity limited by symptoms of angina, congestive heart failure, chronic obstructive pulmonary disease, or arthritis to be determined by PI 9. patients who have undergone vascular surgery or endovascular surgery in the previous year on the affected leg 10. history of major lower extremity amputation 11. history of major psychiatric disorder 12. history of uncontrolled hypertension |
Resultat
Mesures de resultats primaris
1. Peak walking time [2 weeks]
Mesures de resultats secundaris
1. Muscle Fatigue [2 weeks]
2. Claudication onset time [2 weeks]
