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Exercise for People With Peripheral Neuropathy and Diabetic Foot Ulcers - a Case Series on Feasibility and Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065724
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
Kajsa Lindberg, Københavns Kommune

Brief Summary:

Physical training is one of the cornerstones within the treatment of diabetes, as well as medicine and diet modification, and the effect is well documented. Nevertheless people with diabetes with foot ulcers are urged to lessen their level of physical activity, to reduce pressure on footbed and thereby achieve fastest possible healing.

Purpose: The primarily purpose is to investigate the feasibility of implementing safe, progressive resistance training, combined with exercises for ankle mobility and aerobic training, for people with diabetes and foot ulcers, without compromising the ulcer. The secondarily purpose is to investigate whether this form of training is effective on improving muscle strength, as to if limitations in everyday life diminishes.

The hypothesis is, that it is possible to implement a structured exercise program without compromising the diabetic ulcer.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Foot Ulcer Other: Physical training as resistance and aerobic training. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Exercise Programme for People With Severe Peripheral Neuropathy and Diabetic Foot Ulcers - a Case Series on Feasibility and Safety
Study Start Date : February 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Physical training resistance and aerobic
Physical training as resistance and aerobic training
Other: Physical training as resistance and aerobic training.



Primary Outcome Measures :
  1. 10 Repetition Maximum (RM)for knee flexor, knee extensor, hip abductor, low row [ Time Frame: 10 weeks after entering exercise programme ]
    Change in strength measured by 10 Repetition Maximum(RM)

  2. Patient Specific Functional Scale(PSFS) [ Time Frame: 10 weeks after entering exercise programme ]
    Change in ability to perform everyday life tasks, scale from 0-10, 0=can not perform, 10=same level as before ulcer

  3. Endurance cycling on stationary bike [ Time Frame: 10 weeks after entering exercise programme ]
    Change in number of km in 12 min

  4. Number of ankle dorsiflexion repetitions [ Time Frame: 10 weeks after entering exercise programme ]
    Change in maximum number of repetitions with elastic band

  5. Ulcer area [ Time Frame: 10 weeks after entering exercise programme ]
    Change in ulcer area measured in cm2


Secondary Outcome Measures :
  1. Participant satisfaction measured by Numeric Rating Scale(NRS) [ Time Frame: 10 weeks after entering exercise programme ]
    Participant scores satisfaction with programme 0=lowest possible satisfaction 10=highest possible satisfaction



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with stable, diabetic ulcer on foot sole in treatment by nurse
  • who speaks and understands Danish
  • are able to give consent
  • are allowed to walk at least short distances
  • above 18 years old
  • are able to participate in group exercises

Exclusion Criteria:

  • patients with infection in ulcer
  • with critical ischemia(<40 mm Hg toe pressure)
  • not accepted to participate by answering doctor with regards to safety on renal, heart or eye function
  • dyspnea to an extent, that affects speaking
  • wheel chair user

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065724


Locations
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Denmark
Rehabilitation Centre Vanloese
Copenhagen, Vanloese, Denmark, 2720
Sponsors and Collaborators
Københavns Kommune
Copenhagen University Hospital, Hvidovre
Investigators
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Principal Investigator: Kajsa Lindberg, PT Vanloese Rehabilitation Centre, Community of Copenhagen
Study Chair: Morten Tange Kristensen, ph d, senior researcher Dpt of Physiotherapy and Dpt of Orthopaedic Surgery, University Hospital of Copenhagen, Capital Region of denmark
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Responsible Party: Kajsa Lindberg, PT, supervisor, Københavns Kommune
ClinicalTrials.gov Identifier: NCT04065724    
Other Study ID Numbers: KoebenhavnsKommune
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Keywords provided by Kajsa Lindberg, Københavns Kommune:
diabetes mellitus
foot ulcer
resistance training
exercise
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Foot
Foot Ulcer
Diabetes Mellitus
Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Foot Diseases
Neuromuscular Diseases
Nervous System Diseases