AzTrials
AzTrials

Resistance TrainingNCT06240962

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

A study testing Strength Training and Mindfulness Exercise in people with Resistance Training and Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
Strength Training and Mindfulness Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
20 Oct 2023to 20 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malia Younas, MS DPT contact

0325-8292286

maliayounas62@gmail.com

Pakistan1 site, 1 recruiting

  • Pakistan sports board

    Lahore, Punjab Province, 53700

    Rehan Khalid, bachelors, +92-3214078057, rehank14@gmail.com

    Sana Malik, DPT, 0324-8843373, sanaamalik2626@gmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Strength Training, Mindfulness Exercise
Keywords
Mindfulness Practice, Resistance Training, Pain, Sprinters, Patellofemoral Pain Syndrome
Medical subject headings
Patellofemoral Pain Syndrome, Kinesiophobia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strength TrainingOther

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

  • Mindfulness ExerciseOther

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

Study groups in NCT06240962
Study groupRoleWhat they receive
Strength TrainingOtherThey 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.
Receives: Other: Strength Training
Mindfulness ExerciseOtherThey will receive the mindfulness-exercise group will receive an 6-week mindfulness intervention in addition to the strength training protocol.
Receives: Other: Mindfulness Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee Pain

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

    Measured: pre and 6 weeks post interventional

  2. Kinesiophobia

    Tampa Scale will be used to assess kinesiophobia.

    Measured: pre and 6 weeks post interventional

  3. Physical Function

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

    Measured: pre and 6 weeks post interventional

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start20 Oct 2023
  3. Primary completion20 Feb 2024 (estimated)
  4. Study completion20 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized clinical trail
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06240962
Sponsor's protocol ID
REC/RCR&AHS/23/0434
Status last verified
Jan 2024
First submitted
28 Jan 2024
Last updated
5 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22827721

  • 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.

    PubMed 24569145

  • 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.

    PubMed 24691626

  • 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.

    PubMed 30368045

  • 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.

    PubMed 23081711

  • 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.

    PubMed 29362256

  • 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.

    PubMed 19565153

  • 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.

    PubMed 22487407

Questions about this trial

What is this clinical trial studying?

A study testing Strength Training and Mindfulness Exercise in people with Resistance Training and Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Malia Younas, MS DPT (0325-8292286, maliayounas62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Pain (time frame: pre and 6 weeks post interventional). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06240962, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in