NCT03641781

Brief Summary

Frequent sports events causing more injuries in athletes causing decline in their performance. Injuries around knee joint are common. Strength training of hamstring and quadriceps are effective tool in rehabilitation. The multi-speeds and multi-angles strength training plans were used to see the effects on symptoms and performance in athletes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

August 15, 2018

Last Update Submit

August 20, 2018

Conditions

Keywords

Isokinetic, Isometric, AgilityAthletic Single Leg Stability,Vertical Jump Biodex, Knee Pain

Outcome Measures

Primary Outcomes (3)

  • change in Agility Run Test time

    The agility run test was conducted by placing cones at the non-slippery surface. The time to complete the test was recorded by using stop watch. A 10 Meter distance in figure of 8 was made on ground with help of cones. Time taken to complete was recorded in seconds.

    change from baseline through completion an average of 3 weeks

  • change in Vertical Jump test height

    Vertical jump test was conducted by using the measuring tape placed on wall. Athletes were standing along the wall and the standing height, the highest level of finger touching the wall was recorded initially. Athlete then jumped vertically and marked on the wall and performed three repetitions. The greatest difference between initial standing height and after jump height was recorded as score of vertical jump.

    change from baseline through completion an average of 3 weeks

  • change in Athletic single leg stability test

    The athletic single leg stability test was used to assess the stability of athlete conducted by using Biodex Balance System SD (Biodex Medical Systems, Inc. NY, USA). Athletes were standing on involved leg and platform setting was at level 4. Athletes performed 3 repetitions of 20 seconds each with 10 seconds rest between the repetitions to complete the test. Overall stability index, anterior posterior index, and medial lateral index were recorded.

    change from baseline through completion an average of 3 weeks

Secondary Outcomes (1)

  • change in Peak Torque value (FT-LB)

    change from baseline through completion an average of 3 weeks

Study Arms (3)

Isometric strength training group

ACTIVE COMPARATOR

Knee pain athletes were assessed by The International Knee Documentation Committee (IKDC) 2000 Subjective Knee evaluation form and were assigned into ISOM group. ISOM group participants were involved in isometric strengthTraining at angle of 30°,45°,60° of knee flexion for 5 maximum contraction for both hamstring and quadriceps. 10 sessions were given on alternate day basis by using Biodex Isokinetic system.

Other: isometric strength training and isokinetic strength training

Isokinetic strength training group

ACTIVE COMPARATOR

Knee pain athletes were assessed by The International Knee Documentation Committee (IKDC) 2000 Subjective Knee evaluation form and were assigned into ISOK group isokinetic training group randomly. ISOk group participants were involved in Training at speed of 30 deg/sec, 90deg/sec, 150/deg/sec 210deg/sec, 270deg/sec 5 repetition for both hamstring and quadriceps. 10 sessions were given on alternate day basis by using Biodex Isokinetic system.

Other: isometric strength training and isokinetic strength training

Healthy control group

NO INTERVENTION

Data for outcome parameters including Peak torque average peak torque average power agonist antagonist ratio by using biodex isokinetic system for both by isometric contraction method and isokinetic method. For performance test were recorded for healthy control of same age group to compare the training effect with healthy control values.

Interventions

Isokinetic strength program included strength training at 5 different velocities from slow to fast. Participants were trained on speed of 30°/sec, 90°/sec, 150°/sec, 210°/sec and 270°/sec. Flexion and extension movements were completed with 5 repetitions at each speed. Participants of isometric strength training group performed isometric contractions at 30°, 45° and 60° of knee flexion with five repetitions at each angle for both hamstring and quadriceps.

Isokinetic strength training groupIsometric strength training group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The adult athletes between ages 18 to 35 years.
  • Athletes with unilateral knee pain.
  • Both male and female.

You may not qualify if:

  • Athletes with bilateral knee pain and any deformity around knee were excluded from this study.
  • Any other joint involvement of lower limb while assessment were also excluded from study.
  • Athletes with recent history of surgeries for fractures or ligamentous reconstruction were excluded from this study.
  • Patients who were medically unstable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Athletes were randomly assigned into two groups: Isometric (ISOM) and Isokinetic (ISOK). A coin was flipped at start of data collection for the first patient to be assigned odd number and included in isometric group. Later on odd and even numbered patients were included in specific group. Additionally, data was collected from healthy athletes doing their training at Pakistan Sports Board, called healthy control group. Due to ethical constraints knee pain athletes were not included as control subjects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 22, 2018

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

August 22, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR