Clinical Trials Logo
  1. Home
  2. Body Weight Changes
  3. NCT05692401
  4. Details
NCT05692401 Clinical Trial

Weight Change With Controlled Ankle Movement (CAM) Boot Use

Body Weight Changes Clinical Trial

— CAM  

Official title:
Weight Change With Controlled Ankle Movement (CAM) Boot Use

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05692401
Other study ID # STUDY 00021093
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 7, 2023
Est. completion date December 2026

Study information
Verified date December 2023
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date December 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - Age greater or equal to 18 years - Participants with foot or ankle injury who are prescribed a CAM boot as standard of care - Participants willing to have height and weight measured at the time of enrollment and final visit - Participant is able to provide voluntary, written consent - Fluent in written and spoken English - Participant in the opinion of the Principal Investigator, is able to understand the clinical investigation Exclusion Criteria: - Age less than 18 years - Pregnant women - Participants with vertigo or other balance issues - Participants unable to provide informed consent - Participants with foot or ankle injury who will not be wearing a CAM boot - Participants unable/unwilling to perform upper body exercises and follow nutrition recommendations

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight change Height and weight recorded at enrollment and discontinuation of CAM boot 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04578067 - Empowering Immigrant Women for Active and Healthy Lifestyle N/A
Completed NCT02229708 - Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity N/A
Completed NCT00065052 - Modifying the Home Television Watching Environment N/A
Completed NCT04340388 - Contribution of Dolutegravir to Obesity and Cardiovascular Disease Phase 4
Completed NCT04997447 - Enforced Reduction in Physical Activity and Recovery in Older Adults N/A
Active, not recruiting NCT03843424 - Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers N/A
Completed NCT04559542 - Body Weight Regulation, Disordered Eating Behaviour, and Experiences of Sexual Harassment in Female Martial Art Athletes
Not yet recruiting NCT06464497 - Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity N/A
Recruiting NCT04554758 - Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation N/A
Recruiting NCT06078150 - Effects of Active Video Games on Chinese Overweight and Obese College Students' Physical and Mental Health N/A
Recruiting NCT02966444 - Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition N/A
Completed NCT01061346 - Effect of Dietary Fat When Eaten With Fructose Versus Glucose N/A
Recruiting NCT03917758 - Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors N/A
Completed NCT06132269 - Evaluation the Effect of AKK Formula on Intestinal Microbiota Regulation and Body Composition N/A
Completed NCT03524521 - Body Weight-Based Interval Training in Sedentary Overweight and Obese Adults N/A
Active, not recruiting NCT02737267 - Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit) N/A
Completed NCT02554318 - Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia N/A
Completed NCT01820702 - Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation N/A
Completed NCT03480464 - App-technology to Improve the Level of Physical Activity After Bariatric Surgery N/A
Completed NCT03372109 - Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain N/A