Baropodometric Parameters Variation With Body Weight Loss

NCT04809441 | Completed DMC

• 1 other identifier: Podo-C.P.-C.I.PI17/020
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Background: One of the major public health problems of the 21st century is obesity. Baropodometry is commonly used to determine specific loads on the plantar surface of the foot and the comportment of the body center of pressure (CoP). To evaluate the redistribution of the baropodometric parameters: static and dynamic plantar pressures and antero - posterior CoP, by decreasing body weight. Methods: A sample of 43 overweight subjects (24 male, 19 female) would be recruited for the study. A hypocaloric diet would be designed with the aim to reduce participants body weight. The baropodometric exam would performed in two occasions: weight 1 - Session 1 and weight 2 - Session 2, when participants lost between 12 and 18 kg. The foot would be divided in 9 areas: heel, midfoot, 5 metatarsal heads (MTHs), Hallux, 2-5 toes. The Footwork® pressure platform would be used to carry out the evaluation.

Conditions

Postural Imbalance; Obesity

Keywords

Pressure; Static posture; Dynamic

Outcome Measures

Primary Outcomes (4)

• Weight change

  Weight change would be measured at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant lost between 11-12 percent of its corporal weight. Therefore, we will obtain 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2.

  baseline, before procedure and immediately after the procedure

• Static pressure change

  For the static pressure, participants would be asked to stand in the center of the plantar pressure platform for 5 seconds, with their arms on either side of the body in a natural position looking straight ahead. Both feet would be subdivided into 9 pressure areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes. Whre maximun and mean static pressures would be measured.

  baseline, before procedure and immediately after the procedure

• Dynamic pressure change

  For the dinamic pressure, participants would be asked to walk throught the plantar pressure platform at they preferred speed. Both feet would be subdivided into 9 pressure areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes. Whre maximun and mean dynamic pressures would be measured.

  baseline, before procedure and immediately after the procedure

• Cop change

  Displacement from Session 1 to Session 2 position of the Center of pressures obteined with the pressure platform

  baseline, before procedure and immediately after the procedure

Study Arms (1)

Weight loss group

EXPERIMENTAL

Participants were rigorously evaluated by the same endocrine doctor and podiatrist at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant had lost between 11-12% of its corporal weight. Therefore, we obtained 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2.

Other: Diet change

Interventions

Diet change OTHER

A specific very low-calorie diet (\<800kcal/day), and 2 daily sessions of 15 minutes of anaerobic physical exercise depending on the capacity of the participants, were designed

Weight loss group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight subjects
• between 18 and 65 years old
• medical weight loss indicated
• no lower limb or spine pathology that might affect normal gait, nor structural or functional deformities in the feet.

You may not qualify if:

• reported pain in their feet within the previous 6 months
• had any previous foot surgery

Sponsors & Collaborators

• Fundacion Podoactiva: lead

Study Sites (1)

Alejandro Jesús Almenar Arasanz

Zaragoza, 50001, Spain

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: March 22, 2021
• Study Start: June 10, 2019
• Primary Completion: November 10, 2019
• Study Completion: December 14, 2019
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

ES (1)