NCT04065724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

March 12, 2019

Last Update Submit

August 21, 2019

Conditions

Diabetes MellitusFoot Ulcer

Keywords

diabetes mellitusfoot ulcerresistance trainingexercise

Outcome Measures

Primary Outcomes (5)

  • 10 Repetition Maximum (RM)for knee flexor, knee extensor, hip abductor, low row

    Change in strength measured by 10 Repetition Maximum(RM)

    10 weeks after entering exercise programme

  • Patient Specific Functional Scale(PSFS)

    Change in ability to perform everyday life tasks, scale from 0-10, 0=can not perform, 10=same level as before ulcer

    10 weeks after entering exercise programme

  • Endurance cycling on stationary bike

    Change in number of km in 12 min

    10 weeks after entering exercise programme

  • Number of ankle dorsiflexion repetitions

    Change in maximum number of repetitions with elastic band

    10 weeks after entering exercise programme

  • Ulcer area

    Change in ulcer area measured in cm2

    10 weeks after entering exercise programme

Secondary Outcomes (1)

  • Participant satisfaction measured by Numeric Rating Scale(NRS)

    10 weeks after entering exercise programme

Study Arms (1)

Physical training resistance and aerobic

OTHER

Physical training as resistance and aerobic training

Other: Physical training as resistance and aerobic training.

Interventions

Physical training as resistance and aerobic training.OTHER
Physical training resistance and aerobic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Centre Vanloese

Copenhagen, Vanloese, 2720, Denmark

Location

MeSH Terms

Conditions

Diabetes MellitusFoot UlcerMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin UlcerBehavior

Study Officials

  • Kajsa Lindberg, PT

    Vanloese Rehabilitation Centre, Community of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Morten Tange Kristensen, ph d, senior researcher

    Dpt of Physiotherapy and Dpt of Orthopaedic Surgery, University Hospital of Copenhagen, Capital Region of denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, supervisor

Study Record Dates

First Submitted

March 12, 2019

First Posted

August 22, 2019

Study Start

February 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

DK(1)