An interventional study of Nutrition and Exercise Instruction in Ankle Injuries, Foot Injuries and Disorders and Body Weight Changes, sponsored by Nell Blake, DPM. Terminated at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Nell Blake, DPM · Not applicable, Interventional, and Treatment
The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.
The study objectives include: 1) Determine if patients wearing a CAM (Controlled Ankle Movement) boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines at the time the CAM is dispensed and perform upper body exercises through the treatment period. 2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period. 3) To qualitatively explore if the intervention helped to prevent gain weight during post-operative recovery when CAM boot is used
352 studies on the registry are indexed under Ankle Injuries; 72 are open to participants now.
This study's enrollment of 5 is below the median of 56 across 273 interventional studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →Nell Blake, DPM is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
CAM boot prescribed as standard of care. No nutritional guidelines or upper body exercises instructions provided. Height and weight recorded at enrollment and final visit.
CAM prescribed as standard of care. Nutritional guidelines provided and upper body exercise instructions provided. Height and weight recorded at enrollment and final visit. Subjects in this group will undergo a follow up interview that will ultimately be used to examine and assess the helpfulness of the intervention in preventing weight for CAM boot wearing patients.
Behavioral: Nutrition and Exercise Instruction
Eating and exercise patterns. Educational handouts and instructions will be provided, which are intended as a guide for subjects in intervention group. Subjects will also be given a Patient Diary to complete their daily meal intake and physical exercises. Use of and return of the diary is optional but encouraged. It has been found that use of a patient diary to record food intake keeps one from eating more than they planned and can be a useful tool in weight control.
Weight change
Height and weight recorded at enrollment and discontinuation of CAM boot
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Nell Blake, DPM