NCT06240962

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 28, 2024

Last Update Submit

January 28, 2024

Conditions

Resistance TrainingPatellofemoral Pain SyndromeKinesiophobiaSprinters

Keywords

Mindfulness PracticeResistance TrainingPainSprintersPatellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (3)

  • Knee Pain

    Usual pain, pain during stepping and running will be assessed using visual analog scales.

    pre and 6 weeks post interventional

  • Kinesiophobia

    Tampa Scale will be used to assess kinesiophobia.

    pre and 6 weeks post interventional

  • Physical Function

    Functional limitations of the knee will be assessed using the Knee Outcome Survey.

    pre and 6 weeks post interventional

Study Arms (2)

Strength Training

OTHER

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

Mindfulness Exercise

OTHER

They will receive the mindfulness-exercise group will receive an 6-week mindfulness intervention in addition to the strength training protocol.

Other: Mindfulness Exercise

Interventions

Strength TrainingOTHER

They will receive the strength training only (6 weeks, 3 sessions/week) that feature training modifications to help control injury-related symptoms.

Strength Training
Mindfulness ExerciseOTHER

They will receive mindfulness-exercise for 6-week mindfulness intervention in addition to the strength training protocol.

Mindfulness Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan sports board

Lahore, Punjab Province, 53700, Pakistan

RECRUITING

Related Publications (8)

  • Lopes AD, Hespanhol Junior LC, Yeung SS, Costa LO. What are the main running-related musculoskeletal injuries? A Systematic Review. Sports Med. 2012 Oct 1;42(10):891-905. doi: 10.1007/BF03262301.

    PMID: 22827721BACKGROUND

  • Witvrouw E, Callaghan MJ, Stefanik JJ, Noehren B, Bazett-Jones DM, Willson JD, Earl-Boehm JE, Davis IS, Powers CM, McConnell J, Crossley KM. Patellofemoral pain: consensus statement from the 3rd International Patellofemoral Pain Research Retreat held in Vancouver, September 2013. Br J Sports Med. 2014 Mar;48(6):411-4. doi: 10.1136/bjsports-2014-093450. No abstract available.

    PMID: 24569145BACKGROUND

  • Domenech J, Sanchis-Alfonso V, Espejo B. Changes in catastrophizing and kinesiophobia are predictive of changes in disability and pain after treatment in patients with anterior knee pain. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2295-300. doi: 10.1007/s00167-014-2968-7. Epub 2014 Apr 2.

    PMID: 24691626BACKGROUND

  • Mansfield CB, Selhorst M. The effects of fear-avoidance beliefs on anterior knee pain and physical therapy visit count for young individuals: A retrospective study. Phys Ther Sport. 2018 Nov;34:187-191. doi: 10.1016/j.ptsp.2018.10.008. Epub 2018 Oct 18.

    PMID: 30368045BACKGROUND

  • Domenech J, Sanchis-Alfonso V, Lopez L, Espejo B. Influence of kinesiophobia and catastrophizing on pain and disability in anterior knee pain patients. Knee Surg Sports Traumatol Arthrosc. 2013 Jul;21(7):1562-8. doi: 10.1007/s00167-012-2238-5. Epub 2012 Oct 19.

    PMID: 23081711BACKGROUND

  • Smith BE, Moffatt F, Hendrick P, Bateman M, Rathleff MS, Selfe J, Smith TO, Logan P. The experience of living with patellofemoral pain-loss, confusion and fear-avoidance: a UK qualitative study. BMJ Open. 2018 Jan 23;8(1):e018624. doi: 10.1136/bmjopen-2017-018624.

    PMID: 29362256BACKGROUND

  • Piva SR, Fitzgerald GK, Wisniewski S, Delitto A. Predictors of pain and function outcome after rehabilitation in patients with patellofemoral pain syndrome. J Rehabil Med. 2009 Jul;41(8):604-12. doi: 10.2340/16501977-0372.

    PMID: 19565153BACKGROUND

  • Rathleff MS, Rasmussen S, Olesen JL. [Unsatisfactory long-term prognosis of conservative treatment of patellofemoral pain syndrome]. Ugeskr Laeger. 2012 Apr 9;174(15):1008-13. Danish.

    PMID: 22487407BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain SyndromeKinesiophobiaPain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPhobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sana Malik, DPT

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malia Younas, MS DPT

CONTACT

0325-8292286maliayounas62@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the assessor who will take the readings is blind
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized clinical trail
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

October 20, 2023

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)