Mindfulness Practice vs Strength Training on Pain, Kinesiophobia and Function Among Sprinters

January 28, 2024 updated by: Riphah International University

Effects of Mindfulness Practice With Strength Training on Pain, Kinesiophobia and Function Among Sprinters With Patellofemoral Syndrome

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A & B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive the strength training only. Group B will receive the mindfulness-exercise in addition to the strength training protocol.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to determine the effects of mindfulness practice with strength training on pain, kinesiophobia and function among sprinters with patellofemoral syndrome. The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A & B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive the strength training only. Group B will receive the mindfulness-exercise in addition to the strength training protocol. Usual pain, pain during stepping, and pain during running will be assessed using visual analog scales. Functional limitations of the knee will be assessed using the Knee Outcome Survey. Fear of movement, pain catastrophizing, and coping strategies will be measured via the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, and the Coping Strategies Questionnaire, respectively. For strength training we will use Muscle-strengthening Exercise Questionnaire Short Form (MSEQ). These outcomes will be assessed at baseline and after 6 weeks

The data will be analyzed by SPSS, version 25. Statistical significance is P=0.05.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • 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 Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 53700
        • Recruiting
        • Pakistan Sports Board
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sana Malik, DPT
        • Sub-Investigator:
          • Malia Younas, MS DPT

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males and Female between the ages of 18 and 40 years, Report running ≥2 times per week for >45 minutes or a minimum weekly running distance of 10 km, Present a history of insidious onset of signs and symptoms of PFP in 1 or both knees that was unrelated to trauma for at least 3 months before assessment, score <85/100 on the Activities of Daily Living Scale and Sports related of the Knee Outcome Survey (KOS-ADLS)

Exclusion Criteria:

  • Intra-articular condition, Coexisting lower limb injury, History of patellar dislocation or knee surgery, Osgood-Schlatter or Sinding- Larsen-Johansson syndrome

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
Intervention / Treatment
Other: Strength Training
They will receive the strength training only will follow a protocol (6 weeks, 3 sessions/week) that feature training modifications to help control injury-related symptoms.
Other: Strength Training
They will receive the strength training only (6 weeks, 3 sessions/week) that feature training modifications to help control injury-related symptoms.
Other: Mindfulness Exercise
They will receive the mindfulness-exercise group will receive an 6-week mindfulness intervention in addition to the strength training protocol.
Other: Mindfulness Exercise
They will receive mindfulness-exercise for 6-week mindfulness intervention in addition to the strength training protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Pain
Time Frame: pre and 6 weeks post interventional
Usual pain, pain during stepping and running will be assessed using visual analog scales.
pre and 6 weeks post interventional
Kinesiophobia
Time Frame: pre and 6 weeks post interventional
Tampa Scale will be used to assess kinesiophobia.
pre and 6 weeks post interventional
Physical Function
Time Frame: pre and 6 weeks post interventional
Functional limitations of the knee will be assessed using the Knee Outcome Survey.
pre and 6 weeks post interventional

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sana Malik, DPT, Study Principal Investigator

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)

October 20, 2023

Primary Completion (Estimated)

February 20, 2024

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0434

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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