Effects of Pes Planus on Quality of Life

The Effect of Pes Planus on Physical Activity Level, Exercise Capacity and Quality of Life in Young Adults

This study will be conducted to investigate the effect of pes planus on physical activity level, exercise capacity and quality of life in young adults. In the study, various evaluations and questionnaires will be applied to the participants by dividing them into two groups by performing the navicular drop test. In the study, questionnaires and applications such as Digital dynamometer measurements, Foot Function Index (AFI), International Physical Activity Questionnaire (IPAQ), 6 Minute Walk test, blood pressure, heart rate, saturation measurements, Modified Borg Scale and SF-36 quality of life questionnaire will be used.

Study Overview

• Status: Not yet recruiting
• Conditions: Pes Planus
• Intervention / Treatment: Other: Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scale

Detailed Description

The aim of this study is to investigate the effect of pes planus on physical activity level, exercise capacity and quality of life in young adults. There are studies examining the effects of pes planus on physical fitness, quality of life, balance and pain levels. However, there are no studies evaluating the effect of pes planus on exercise capacity and physical activity level. It will enable us to have information about its capacity and its effect on quality of life and to obtain workable data. Thanks to these data, the orientation towards treatment options for the negative effects of pes planus will increase. After the approval of the ethics committee, 32 participants who meet the inclusion criteria will be included in the study. The participants will be divided into two groups, 16 with pes planus and 16 without pes planus, by performing the navicular drop test. The foot muscle strength of the participants will be measured with a digital muscle strength device (Lafayette Manual Muscle). The International Physical Activity Questionnaire (IPAQ) will be used for the physical activity level of the participants, the 6-minute walking test for the exercise capacity, the SF-36 quality of life questionnaire for the quality of life, and the Foot Function Index (AFI) for the foot functional status. Heart rate, blood pressure, borg value and oxyhemoglobin value will be measured before and after the 6-minute walking test to be performed on the participants. According to these measurements, the physical activity levels, exercise capacities and quality of life of the participants in both groups will be compared.

• Study Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

• Study Contact: Name: Esra PEHLİVAN, assoc.prof; Phone Number: 02163463636; Email: esra.pehlivan@sbu.edu.tr
• Study Contact Backup: Name: Meryem ÖZDEMİR; Phone Number: 05435088786; Email: ozdemirmeryem248@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Young adults aged 18-30 years

Description

Inclusion Criteria:

• Being between the ages of 18-30,
• Being able to walk independently (Can use a walking aid)
• Not having a diagnosed psychiatric disorder.

Exclusion Criteria:

• Presence of inflammatory, systemic, degenerative and neurological diseases of the foot and ankle,
• Presence of standing equine, hallux valgus and hallux rigidus deformities
• Current history of surgery related to the foot-ankle,
• Existence of cooperation disorders that would prevent participation in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals with a pes planus; Navicular drop test, International Physical Activity Questionnaire (IPAQ), Digital dynamometer measurement, SF-36 quality of life Questionnaire, 6 Minutes Walk test, Foot Function Index, borg value, heart rate, blood pressure, oxyhemoglobin values will be measured for individuals with pes planus.	Other: Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scale; Pulse oximetry will be used to measure the oxyhemoglobin value of the participants, and a sphygmomanometer will be used for blood pressure and heart rate measurements.; Other Names: Device Sphygmomanometer, pulseoximeter
Individuals Without Giving Up Planus; Navicular drop test, International Physical Activity Questionnaire (IPAQ), Digital dynamometer measurement, SF-36 quality of life Questionnaire, 6 Minutes Walk test, Foot Function Index, borg value, heart rate, blood pressure, oxyhemoglobin values will be measured for individuals with pes planus.	Other: Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scale; Pulse oximetry will be used to measure the oxyhemoglobin value of the participants, and a sphygmomanometer will be used for blood pressure and heart rate measurements.; Other Names: Device Sphygmomanometer, pulseoximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Navicular Drop Test	It will be used to determine whether participants have pes planus. Participants will undergo a navicular drop test to assess arch height, flexibility, and standing pronation. In the sitting position where the participants do not carry weight with bare feet, while their feet are in contact with the ground, a mark will be placed on the card on the floor at the level of the navicular tubercle. Then, on the same card, a mark will be made on the same card at the level of the navicular tubercle in the position where they stand up with full weight on the same card. The difference in the distance between the two marked lines will be recorded as the amount of navicular fall in mm. Participants with a diameter of 10 mm or more in the group will be evaluated in the group with pes planus.	Baseline
Muscle Strength	With the digital muscle strength device, muscle strength assessment will be made on the muscles of the participants who have foot dorsiflexion, plantarflexion, inversion and eversion.	Baseline
6 minutes walking test	The exercise capacity of the participants will be evaluated with the 6-minute walking test.	6 minutes
International Physical Activity Questionnaire-Short form (IPAQ)	The physical activity levels of the participants will be evaluated with the International Physical Activity Questionnaire-Short Form (IPAQ). According to the questions in the questionnaire, metabolic equivalent (MET) scores were determined according to how many days per week, how many hours or minutes per day the activities were performed. According to the survey, it will be determined that as metabolic equivalents increase, physical activity levels are higher, and as they decrease, it will be lower.	Baseline
Foot Function Index	The foot function status of the participants will be evaluated with the Foot Function Index (AFI). It is a 23-item questionnaire and each item will be given a value between 0-10 according to the visual analog scale and a score will be made between 0-100. The average of all scores will be taken during the calculation. A higher calculated value means more activity limitation, disability, and more pain.	Baseline
SF-36 quality of life questionnaire	The quality of life of the participants will be evaluated with the Short Form Health Survey (SF-36 Short Form) consisting of 36 questions. This questionnaire evaluates the positive and negative aspects of health status. As a result of the survey, a value between 0-100 will be found. A high score from the scale indicates good quality of life.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Borg Scale	Before and after the 6-minute walk test, the fatigue levels of the participants will be evaluated with the Modified Borg Scale. According to the modified borg scale, participants will score their fatigue with a value between 0 and 10. As the value said by the participants approaches 10, it will be determined that their fatigue levels increase.	Baseline

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Study Director: Esra PEHLİVAN, Assoc.Prof, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise Capacity; Life Quality
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: Effects of Giving Up Planus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No