- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03965520
Exercise Test and Sequential Training Strategies in PAD
Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease
Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness.
In past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease.
To enhance exercise capacity in patients with PAD may involve redistribution of blood flow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood flow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood flow, and possible increased muscle capillary density and mitochondrial capacity.
Therefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness.
In past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease.
To enhance exercise capacity in patients with PAD may involve redistribution of blood flow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood flow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood flow, and possible increased muscle capillary density and mitochondrial capacity.
Therefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Keelung, Taiwan, 204
- Rekruttering
- Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
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Ta kontakt med:
- Tieh Cheng Fu, MD, PhD
- Telefonnummer: 2626 886-2-24313131
- E-post: mr5598@adm.cgmh.org.tw
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Hovedetterforsker:
- Tieh-Cheng Fu, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Ankle-brachial index <0.9
Exclusion Criteria:
1.<20 years old 2. There are other diseases or behavioral restrictions that prevent exercise training 3. Other exercise contraindications:
- unstable angina
- resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg
- orthostatic blood pressure drop greater than 20 mmHg with symptoms
- Symptomatic severe aortic stenosis
- Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
- Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
- Uncontrolled symptomatic heart failure
- High-degree atrioventricular blocks
- Acute myocarditis or pericarditis
- Acute pulmonary embolus or pulmonary infarction
- a recent significant change in the resting electrocardiogram suggesting significant ischemia,
- recent myocardial infarction (within 2 d), or other acute cardiac events
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: usual training
exercise intensity arranged by cardiopulmonary exercise test results
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We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer
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Eksperimentell: Novel exercise training
exercise intensity monitor by near-infrared spectrometer
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We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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physical fitness (peak oxygen consumption)
Tidsramme: after 36 session exercise training, up to 12 weeks
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oxygen consumption in cc/min/kg measured by Carefusion(TM) during cardiopulmonary exercise test
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after 36 session exercise training, up to 12 weeks
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physical fitness (exercise duration)
Tidsramme: after 36 session exercise training, up to 12 weeks
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exercise duration in seconds measured during cardiopulmonary exercise test
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after 36 session exercise training, up to 12 weeks
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physical fitness (walking distance)
Tidsramme: after 36 session exercise training, up to 12 weeks
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walking distance in meters measured during six minutes walking test
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after 36 session exercise training, up to 12 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 103-4837B
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