Comparative Effects of Clamshells and Frog Pump Exercises

April 29, 2024 updated by: Riphah International University

Comparative Effects of Clamshells and Frog Pump Exercises on Gluteus Medius Strengthening and Lower Extremity Function in Runners With Iliotibial Band Syndrome

Iliotibial band syndrome is where a tendon called iliotibial band gets irritated or swollen from rubbing against hip or knee when it gets too tensed. Iliotibial band (ITB) syndrome (ITBS) is the most common cause of lateral knee pain among athletes who are involved in sports that require continuous running or repetitive knee flexion and extension. The incidence ranges from 1.6% to 12% in runners. The aim of the study is to compare the effects of clamshells and frog pump exercises on gluteus medius strengthening and lower extremity function in runners with iliotibial band syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be a randomized clinical trial and will be conducted in Pakistan Sports Board Lahore. Non-probability convenient sampling will be used to collect the data. Sample size of 32 subjects with age group between 18-30 years (males) will be taken. Data will be collected from the runners with tight ITB, by using tools LEFS, HOS-SS, and Hand held dynamometer. An informed consent will be taken. A total of 26 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both the Groups will continue the conventional training with Group A will receive clamshell Exercise, and Group B will receive frog pump exercise in their respective training programs. Outcome measures will be measured at baseline and after 2 weeks. Data analysis will be done by SPSS version 25.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54000
        • Pakistan Sports Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Age (18-30yrs)

    • Gender (Males)
    • Positive Ober's test
    • Positive Noble's compression test
    • Suffering pain from past 3 months
    • Running approximately 5km/week

Exclusion Criteria:

  • • Osteoporosis

    • Previous knee trauma/surgery
    • Patellofemoral joint pain
    • Popliteus tendinitis
    • Lateral meniscal injure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A: Clamshell Exercise

Group B will be given frog pumps exercises in their regular training program.

These exercises are given as:

  • In (0-2) week ,2 sets 10 repetitions
  • In (2-4)week, 3 sets of 10 repetitions
  • In (4-6)week, 3 sets of 15 repetitions
Other: Clamshell Exercise
Clamshell Exercise: The clamshell exercise keeps the hips moving, it strengthens both the gluteus medius AND gluteus maximus. The gluteus medius is the main abductor (movement away from the midline of the body) and external rotator of the hip.
Active Comparator: Group B: Frog Pump Exercise

Group B will be given frog pumps exercises in their regular training program.

These exercises are given as:

  • In (0-2) week ,2 sets 10 repetitions
  • In (2-4)week, 3 sets of 10 repetitions
  • In (4-6)week, 3 sets of 15 repetitions
Other: Frog pump exercise
Frog pump exercise: The frog hip thrust mainly targets the gluteal muscles responsible for thigh extension and abduction. The exercise also works the hamstrings on the back of the thighs which helps in hip extension.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Manual Muscle Testing (MMT)
Time Frame: upto 6th weeks

For measuring the strength of Hip muscles, Manual Muscle Testing (MMT) is used.

Manual Muscle Testing (MMT) is a standardised set of assessments that measure muscle strength and function against specific criteria and is commonly used in clinical practice by physiotherapists.

Grading Scale Range: 0 to 5 0 None No visible or palpable contraction

  1. Trace Visible or palpable contraction with no motion
  2. Poor Full ROM gravity eliminated
  3. Fair Full ROM against gravity
  4. Good Full ROM against gravity, moderate resistance
  5. Normal Full ROM against gravity, maximum resistance
upto 6th weeks
Hip Outcome Score (HOS)
Time Frame: upto 6th weeks

The hip outcome score (HOS) is a questionnaire used to measure the function of the Hip.

The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4).
upto 6th weeks
Lower Extremity Functional Scale (LEFS)
Time Frame: upto 6th weeks

The lower extremity functional scale (LEFS) measures the function and disability of the lower extremity.

LEFS is a well-known and validated instrument for the measurement of lower extremity function. The LEFS was developed in a group of patients with various musculoskeletal disorders.

The LEFS rating scale categories are: (1) "extreme difficulty or unable to perform," (2) "quite a bit of difficulty," (3) "moderate difficulty," (4) "a little bit of difficulty," and (5) "no difficulty." LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.
upto 6th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samrood Akram, Mphil, Riphah International University,Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/23/0411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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