The Effect of Exercise on Wound Healing While Off-loading
15 oktober 2021 uppdaterad av: Deborah M. Wendland, Ph.D., Mercer University
The Effect of Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment
This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer.
Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.
Studieöversikt
Detaljerad beskrivning
The purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer.
While benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. It is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. If exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.
Studietyp
Interventionell
Inskrivning (Förväntat)
15
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Deborah M. Wendland, PhD
- Telefonnummer: 6785476775
- E-post: wendland_dm@mercer.edu
Studera Kontakt Backup
- Namn: Teri Biven, DPT
- Telefonnummer: 404.605.2743
- E-post: Teri.Biven@piedmont.org
Studieorter
-
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Georgia
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Atlanta, Georgia, Förenta staterna, 30309
- Rekrytering
- Piedmont Healthcare
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Kontakt:
- Teri Biven, DPT
- Telefonnummer: 404-605-2743
- E-post: Teri.Biven@piedmont.org
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Have diabetes
- Have an active plantar ulceration
- With or without peripheral neuropathy
- Able to safely exercise
- Receiving care for their plantar ulceration, including off-loading
Exclusion Criteria:
- Presence of an untreated infection, osteomyelitis, or gangrene
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Exercise Added to Off-loading
Participants in this arm will participate in exercise at the healthcare facility one time a week (away from where wound care is provided) and be instructed in a home exercise program that they will be encouraged to perform at least three days per week with no more than two days between sessions.
Wound care will continue at the facility as is standard, utilizing off-loading.
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Participants will participate in an exercise session with non-weight-bearing exercise that the participant is able to perform with off-loading (e.g. total contact cast) intact.
They will also be instructed in a home exercise program so that exercise can be performed three days per week with no more than two days between sessions.
These participants will also receive standard wound care with off-loading.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wound measurement size
Tidsram: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
|
Charts will be reviewed for normal wound measurements as is part of standard care.
Measurements are expected to be reported as surface area (cm^2) and/or volume (cm^3).
Wound closure will be defined as epithelialization across the entire wound bed and would be expected to correlate to no surface area or volume of wound being reported.
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Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Summary of Diabetes Self-Care Activities Scale
Tidsram: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Participation in exercise.
Using two questions, this scale measures the number of days that an individual reports doing physical activity (question 1) or specific exercise (question 2).
Scores on each question could range from 0 to 7 days.
The higher the number, the more days the individual participates in the activity or exercise.
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Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Body Mass Index
Tidsram: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Height and weight measurements will be combined and reported as BMI and measured in kg/m^2.
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Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Physical activity data using an activity monitor (e.g. StepWatch).
Tidsram: Measured at baseline for one week.
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A week-long measurement of strides will be taken at the begin of the study.
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Measured at baseline for one week.
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Vibration sense
Tidsram: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Vibration sense will be measured using a Bio-Thesiometer to assess for degree of peripheral neuropathy.
A higher score would indicate decreased sensory perception of vibration.
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Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Waist circumference
Tidsram: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Waist circumference will be taken in cm as a marker of body composition.
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Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Deborah M. Wendland, Mercer University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 maj 2021
Primärt slutförande (Förväntat)
1 maj 2023
Avslutad studie (Förväntat)
1 maj 2023
Studieregistreringsdatum
Först inskickad
19 februari 2020
Först inskickad som uppfyllde QC-kriterierna
19 februari 2020
Första postat (Faktisk)
21 februari 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 oktober 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 oktober 2021
Senast verifierad
1 oktober 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H1908192
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified closure rate data will be made available through a repository upon conclusion of the study and its dissemination.
Tidsram för IPD-delning
Data will be available following the study conclusion and its dissemination (6 months after publication).
Kriterier för IPD Sharing Access
The information will be shared with researchers for meta-analyses through the data repository.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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