Progressive Loading Exercises and Conditioning Exercises on Calf Strain (runners)

March 4, 2024 updated by: Riphah International University

Effects of Progressive Loading Exercises and Conditioning Exercises on Pain, Range of Motion and Functions in Calf Strain Among Runners

Calf pain is a common complaint among runners of all ages but is most frequent in masters athletes. The most common calf injury is a tear of the medial gastrocnemius muscle (Tennis Leg) but other structures including the lateral gastrocnemius, plantaris and soleus also may be the cause of muscular pain.There are multiple techniques for the management that involves loading the strained calf musculature through rest, taping techniques, and appropriate soft tissue massage techniques, modalities such as dry needling or western acupuncture can be popular amongst runners and may also be useful. Progressive loading is a principle of resistance training exercise program design that typically relies on increasing load to increase neuromuscular demand to facilitate further adaptations whereas Athletic performance is based on a number of skills that can be developed through a sports conditioning program. This particular program focuses on improving both muscular strength and power using a technique called post-activation potentiation (PAP), also commonly referred to as complex training.

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

Calf pain is a common complaint among runners of all ages but is most frequent in masters athletes. Calf pain in runners usually results from musculotendinous origins, with the gastrocnemius among the most common of all muscle injuries. The most common calf injury is a tear of the medial gastrocnemius muscle (Tennis Leg) but other structures including the lateral gastrocnemius, plantaris and soleus also may be the cause of muscular pain.There are multiple techniques for the management that involves loading the strained calf musculature through rest, taping techniques, and appropriate soft tissue massage techniques, modalities such as dry needling or western acupuncture can be popular amongst runners and may also be useful. Progressive loading is a principle of resistance training exercise program design that typically relies on increasing load to increase neuromuscular demand to facilitate further adaptations whereas Athletic performance is based on a number of skills that can be developed through a sports conditioning program. This particular program focuses on improving both muscular strength and power using a technique called post-activation potentiation (PAP), also commonly referred to as complex training.

A randomized clinical trial will be conducted at Pakistan sports board, Lahore . Non probability convenience sampling technique will be applied on 40 patients who will be allocated through simple random sampling into group A & group B to collect data. Group A will be given progressive loading exercises and group B will be given conditioning exercises along with stretching. The study will be completed within the time duration of six months. Primary Outcome measures of the research will be pain, range of motion, and functions. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

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.
40

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 Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 38000
        • Jawad club, Alfatah sports complex
      • Faisalābad, Punjab, Pakistan, 5400
        • Riphah International University, Raiwind Campus

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Athletes aged 18 years or above
  • Pain and tenderness at the back of the lower leg
  • self-reported pain ,spasm at back of thigh presenting during sport or at rest (unilateral or bilateral)

Exclusion Criteria:

  • Radiating pain or pain with neurogenic and systemic origin
  • History of lower limb fracture and surgery
  • History of instability at knee or ankle
  • Knee or ankle ligamentous or meniscal injury

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: Treatment
  • 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.
Experimental: progressive loading exercises

progressive loading exercises Progressive loading exercises & stretching protocol will be given. The exercises included are as follows

  • Standing calf raise double leg
  • Standing calf raise single leg 4 sets with 8 repetitions will be given. Session will be given thrice a week for 40 minutes.
  • Soleus wall sits double leg
  • Toe taps
  • Toe walks forward hops double
Procedure: Progressive Loading Exercises
At start of study, a formal educational session, lasting about 30 minutes will be given by the physiotherapist dealing with the treatment/interventions. Whole treatment plan will be given for six weeks. Pre and post intervention measurements will be taken.
Other Names:
  • Conditioning Exercises
Experimental: Conditioning Exercises

conditioning exercises Conditioning exercises & stretching protocol will be given. (31)

  • Standing calf raise
  • Seated calf raise
  • Calf press hold
  • Loaded plant walk
  • Single leg step hops up 4 sets with 8 repetitions will be given. Session will be given thrice a week for 40 minutes.
Procedure: Progressive Loading Exercises
At start of study, a formal educational session, lasting about 30 minutes will be given by the physiotherapist dealing with the treatment/interventions. Whole treatment plan will be given for six weeks. Pre and post intervention measurements will be taken.
Other Names:
  • Conditioning Exercises

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
pain , range of motion, functions
Time Frame: 10 months
these three variables will be measured during the study
10 months

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: Amna Shahid, MS-DPT, Riphah International University

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.
June 1, 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.
February 10, 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.
February 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).
March 4, 2024

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.
March 4, 2024

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.
March 8, 2024

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.
March 8, 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.
March 4, 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.
March 1, 2024

More Information

Terms related to this study

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.
  • amnashahid

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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