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Nutrition and Exercise Instruction for Weight Changes (CAM Trial)

N/A

Waitlist Available

Led By Nell Blake, DPM

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

CAM Trial Summary

This trial looks at how weight changes when using a CAM boot and following nutritional guidelines and upper body exercise.

Who is the study for?

This trial is for adults over 18 with a foot or ankle injury who are prescribed a CAM boot. They must understand the study, be willing to have their height and weight measured, consent voluntarily, and speak English fluently. Pregnant women, those under 18, individuals with balance issues or unable to consent or follow the study's exercise and nutrition guidelines cannot participate.Check my eligibility

What is being tested?

The study aims to see if wearing a CAM boot affects weight change when combined with nutritional advice and upper body exercises compared to just wearing the boot without additional guidance.See study design

What are the potential side effects?

Since this trial involves nutrition and exercise instruction rather than medication, side effects may include muscle soreness from exercise or changes in digestion due to new dietary habits.

CAM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Weight change

CAM Trial Design

2Treatment groups

Active Control

Group I: Nutrition and Exercise InstructionActive Control1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,772 Total Patients Enrolled

Nell Blake, DPMPrincipal InvestigatorPenn State Health Hershey Medical Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Nutrition and Exercise Instruction Clinical Trial Eligibility Overview. Trial Name: NCT05692401 — N/A

Ankle Injury Research Study Groups: Nutrition and Exercise Instruction, Standard of Care

Ankle Injury Clinical Trial 2023: Nutrition and Exercise Instruction Highlights & Side Effects. Trial Name: NCT05692401 — N/A

Nutrition and Exercise Instruction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05692401 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study encompass individuals over 85 years of age?

"As denoted in the eligibility requirements, any patient ages 18 to 89 may enroll in this trial."

Answered by AI

Are there presently any vacancies in the clinical trial?

"According to clinicaltrials.gov, this trial has ceased its recruitment push; it was first posted on May 1st 2023 and the listing had last been updated 17 days prior. However, there are nearly one thousand other active trials presently searching for participants."

Answered by AI

Who can qualify to be involved in this research experiment?

"For this clinical trial, up to 50 patients with foot injuries and disorders aged between 18 years old and 89 are being accepted. Applicants must meet the following qualifications: a minimum age of 18, have been prescribed CAM boots as per standard care protocols, be able to provide height/weight measurements at enrollment & conclusion of study, demonstrate fluency in spoken & written English language, obtain voluntary consent from PI (Principal Investigator), and convincingly display understanding on investigation procedures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Weight Change With Controlled Ankle Movement (CAM) Boot Use

Nell Blake, DPM 2023. "Weight Change With Controlled Ankle Movement (CAM) Boot Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05692401.