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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|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|
Physical training resistance and aerobic
Physical training as resistance and aerobic training
Other: Physical training as resistance and aerobic training.
- 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)
- 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
- Endurance cycling on stationary bike [ Time Frame: 10 weeks after entering exercise programme ]Change in number of km in 12 min
- Number of ankle dorsiflexion repetitions [ Time Frame: 10 weeks after entering exercise programme ]Change in maximum number of repetitions with elastic band
- Ulcer area [ Time Frame: 10 weeks after entering exercise programme ]Change in ulcer area measured in cm2
- 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
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
|Rehabilitation Centre Vanloese|
|Copenhagen, Vanloese, Denmark, 2720|
|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|