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Hip SurgeryNCT03954730

Eccentric Training Versus Active Release Technique On Quadriceps In Patients With Dynamic Hip Screw

A study testing Eccentric Training and Active Release Technique in people with Hip Surgery, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare the effects of Eccentric training and Strength training with priory applied Active Release Technique on Quadriceps muscle in post operative patients of Dynamic Hip screw. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Hip Surgery
What is being tested?
Eccentric Training and Active Release Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 sitePakistan
Study dates
19 Mar 2019to 30 Jun 2019
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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 40-65 years
  • Patient with stable vitals on 3rd post-operative day
  • Postero-Lateral Hip surgical approach

Who cannot join

  • History of prior fracture
  • History of fall
  • Multiple fractures
  • Cognitive impairment (Score ˂26 on Montreal cognitive assessment)
  • Co-morbid disease

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Fauji Foundation Hospital

    Rawalpindi, Punjab Province, 46000

Other trials in Pakistan

About this study

Official title: Comparison Of Eccentric Training And Active Release Technique On Quadriceps Muscle In Patients With Dynamic Hip Screw

This study will compare the effects of Eccentric training and Strength training with priory applied Active Release Technique on Quadriceps muscle in post operative patients of Dynamic Hip screw. Participants would be equally divided into two groups each receiving specific type of protocol besides standard post operative protocol of Dynamic Hip screw

Read the detailed description

The study is Randomized Control Trial, being conducted at Fauji Foundation Hospital Rawalpindi .This study will compare the effects of two techniques addressing the contractile as well as non-contractile element of Quadriceps in early phase of Rehabilitation.

Sample size of 18 was calculated using software Epitool with 95% confidence interval and 80% power. Individuals of selected population will be randomly allocated as 9 in Eccentric group and 9 in Active Release Technique group by sealed enveloped method.

Conditions
Hip Surgery
Being tested
Eccentric Training, Active Release Technique
Keywords
Eccentric training, Active Release Technique

What participants receive

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

  • Eccentric TrainingOther

    First session will be performed 24 hours after pre-training tests i.e. on 4th post- operative day and subsequent sessions will be performed with lapse of 48 hours. During pre-testing, weight for the eccentric training will be determined using Standardized Brzycki formulas for lower limb. Participants will perform one set of 10 repetitions with selected weight. Intensity will be increased every week by decreasing the time of performance. Volume will be increased by increasing one set after two weeks. Eccentric training will be performed in sitting position on dynamic constant external resistance equipment.After session, patient will perform strengthening of quadriceps muscle as per clinical practice guidelines of National Health Service (UK).

  • Active Release TechniqueOther

    Isometric Quadriceps' contractions against therapist's resistance lasting for 10 seconds will be performed by the patient in inner range of knee extension and after relaxing; actively perform maximum full knee flexion. Patient will perform extension at knee joint again; when reaches the innermost range, therapist will apply pressure on deep fascia either through knuckles/fingers or forearm in the direction towards the hip joint and patient is asked to perform knee flexion simultaneously. The procedure is applied onto vastus lateralis, rectus femoris and vastus intermedialis thrice in a session. After session, patient will perform strengthening of quadriceps muscle as per clinical practice guidelines of National Health Service (UK).

Study groups in NCT03954730
Study groupRoleWhat they receive
Eccentric Training GroupExperimentalEccentric training will be performed for quadriceps muscle along with strengthening protocol taken from Clinical Guidelines of NHS for post operative Dynamic Hip Screw rehabilitation.
Receives: Other: Eccentric Training
Active Release Technique GroupActive comparatorActive release technique will be performed for quadriceps muscle along with strengthening protocol taken from Clinical Guidelines of NHS for post operative Dynamic Hip Screw rehabilitation.
Receives: Other: Active Release Technique

What is being measured

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

  1. Numeric Pain Rating Scale (NPRS)

    Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.

    Measured: Baseline

  2. Numeric Pain Rating Scale (NPRS)

    Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.

    Measured: post 6th week

  3. Knee Range of Motion (ROM)

    To assess Knee range of motion (ROM), Goniometer will be use to measure knee range of motion in flexion \& extension. Participants will be seated upright and asked to actively move their knee in each direction.

    Measured: Baseline

  4. Knee Range of Motion (ROM)

    To assess Knee range of motion (ROM), Goniometer will be use to measure knee range of motion in flexion \& extension. Participants will be seated upright and asked to actively move their knee in each direction.

    Measured: post 6th week

Secondary outcomes (2)

  1. Modified Harris Hip score(MHHS)

    The modified Harris hip score (MHHS) is used to assess functional outcomes of hip joint. It is scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain).

    Measured: Baseline

  2. Modified Harris Hip score(MHHS)

    The modified Harris hip score (MHHS) is used to assess functional outcomes of hip joint. It is scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain).

    Measured: post 6th week

Timeline

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

  1. First posted17 May 2019
  2. Study start19 Mar 2019
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There will be two treatment groups of participants, One group will be trained on eccentric graded protocol whereas the other will receive active release technique of quadriceps.
Masking
Single blind
Who is masked
Participant
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03954730
Sponsor's protocol ID
RiphahIU Qurat-ul-ain Saeed
Status last verified
Aug 2019
First submitted
16 May 2019
Last updated
9 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amjad M, Akram R, Zaman AU, Ahmad I, Aziz A. Frequency and Causes of Failure of Dynamic Hip Screw Fixation for Interochanteric Fracture. PAKISTAN JOURNAL OF MEDICAL & HEALTH SCIENCES. 2016;10(3):734-40.

  • Mue D, Salihu M, Awonusi F. Clinical Outcome Following Treatment Of Pertrochanteric Fractures With Dynamic Hip Screw In A Nigerian Rehabilitation Hospital. Journal of Dental and Medical Sciences. 2014;13(10):56-62.

  • Carneiro MB, Alves DP, Mercadante MT. Physical therapy in the postoperative of proximal femur fracture in elderly. Literature review. Acta Ortop Bras. 2013 May;21(3):175-8. doi: 10.1590/S1413-78522013000300010.

    PubMed 24453665

  • Briggs RA, Houck JR, LaStayo PC, Fritz JM, Drummond MJ, Marcus RL. High-Intensity Multimodal Resistance Training Improves Muscle Function, Symmetry during a Sit-to-Stand Task, and Physical Function Following Hip Fracture. J Nutr Health Aging. 2018;22(3):431-438. doi: 10.1007/s12603-017-0977-1.

    PubMed 29484358

  • Briggs RA, Houck JR, Drummond MJ, Fritz JM, LaStayo PC, Marcus RL. Muscle Quality Improves with Extended High-Intensity Resistance Training after Hip Fracture. J Frailty Aging. 2018;7(1):51-56. doi: 10.14283/jfa.2017.31.

    PubMed 29412443

  • Hedayatpour N, Izanloo Z, Falla D. The effect of eccentric exercise and delayed onset muscle soreness on the homologous muscle of the contralateral limb. J Electromyogr Kinesiol. 2018 Aug;41:154-159. doi: 10.1016/j.jelekin.2018.06.003. Epub 2018 Jun 6.

    PubMed 29902705

Questions about this trial

What is this clinical trial studying?

A study testing Eccentric Training and Active Release Technique in people with Hip Surgery, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Aug 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (NPRS) (time frame: Baseline). The study lists 4 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 NCT03954730, which also lists 6 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 9 Aug 2019; AzTrials last refreshed its copy on 2 Nov 2026.

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