Passiv kalvestrækningsterapi ved perifer arteriesygdom
At strække, ikke anstrenge: Indvirkningen af passiv strækning på lægmuskler og gangmekanik i PAD
The goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer are:
- To determine if daily calf muscle stretching at home improves calf muscle and vascular health.
- To determine if daily calf muscle stretching at home improves walking performance.
Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet for 30 minutes a day for 4 weeks. Blood vessel health and size, length and function of the calf muscles and tendons and walking performance will be measured. Joint and foot movements as well as calf muscle oxygen levels will be measured during walking performance tests.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: David N Proctor, Ph.D.
- Telefonnummer: 814-571-5234
- E-mail: dnp3@psu.edu
Undersøgelse Kontakt Backup
- Navn: Jocelyn M Delgado, B.S.
- Telefonnummer: 408-679-8390
- E-mail: jmd956@psu.edu
Studiesteder
-
-
Pennsylvania
-
University Park, Pennsylvania, Forenede Stater, 16802
- Rekruttering
- Penn State University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Presence of PAD
- Stable condition (PAD symptoms) for at least 3 months
- Age 40-85
- Men and women who are not pregnant or nursing
Exclusion Criteria:
- Ischemic leg pain at rest; critical limb ischemia (ulceration or gangrene)
- Any condition other than PAD that limits the ability to walk
- Major surgery or lower extremity revascularization surgery in the past 6 months
- Myocardial infarction within past 6 months or unstable angina
- Severe lung disease (on supplemental oxygen or frequently use rescue inhalers)
- Participants with non-compressible vessels (ABI > 1.40)
- Habitual exercise (30 minutes of continuous activity on 3 or more days per week)
- Current tobacco smoker or use of nicotine-containing products
- Pregnant or nursing women
- History or ankle reconstruction or surgery Recent history (<1 year) of injuries to the ankle, Achilles tendon, or feet
- History of rheumatoid arthritis or other degenerative joint disease
- Major medical illness treatment during the prior 12 months
- Uncontrolled hypertension
- Uncontrolled diabetes
- Inability to walk on a treadmill at a slow pace (1.0 mile/hour)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 4-weeks of passive calf stretching for 30 minutes 5 days a week
A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle. |
Modified night splints will be used to passive stretch the calf muscle.
Andre navne:
|
|
Ingen indgriben: 4-weeks of no-stretching
No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
6-minute walk test distance
Tidsramme: 6-12 minutes
|
Submaximal exercise test used to assess aerobic capacity and endurance |
6-12 minutes
|
|
Muscle to tendon ratio
Tidsramme: 45 minutes
|
The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound |
45 minutes
|
|
Endothelial function
Tidsramme: 30 minutes
|
Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg. |
30 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 00022960
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .