Trial Outcomes & Findings for Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome (NCT NCT04011436)
NCT ID: NCT04011436
Last Updated: 2021-11-23
Results Overview
The Kujala patellofemoral pain scale, is an assessment tool developed to assesses pain and function in patients with disorders of the patellofemoral joint and consists of 13 questions, each with three to five response options, scored from 0 to 5, or 0 to 10, depending on the question. The lowest possible total value is 0 and corresponds to patients who are in a worse functional health condition. The highest possible total value is 100, for those that do not have any alteration and are in optimal condition. The results below, are presented as percentages and 95% confidence interval.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
The next table shows the distribution of the 13 domains of the Kujala´Test by intervention group at baseline (Time point 1, one day before intervention). "Assessed at baseline and after treatment, only baseline pre-specified to be reported".
Results posted on
2021-11-23
Participant Flow
Participant milestones
| Measure |
Core, Hip and Knee.
Physical Exercises to strengthen the core, hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Hip and Knee
Physical Exercises to strengthen the hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Core, Hip and Knee.
n=20 Participants
Physical Exercises to strengthen the core, hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Hip and Knee
n=20 Participants
Physical Exercises to strengthen the hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
18 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
36 Participants
n=40 Participants
|
|
Age, Categorical
Age · >=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
32.5 years
n=20 Participants
|
29 years
n=20 Participants
|
30.75 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
36 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Colombia
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Height
|
160 cm
n=20 Participants
|
159.5 cm
n=20 Participants
|
159.75 cm
n=40 Participants
|
|
BMI
|
25.4 kg/m^2
n=20 Participants
|
23.8 kg/m^2
n=20 Participants
|
24.6 kg/m^2
n=40 Participants
|
|
Fat Percent
|
35.4 percent
n=20 Participants
|
35.4 percent
n=20 Participants
|
35.4 percent
n=40 Participants
|
|
Muscle Percent
|
26.9 percent
n=20 Participants
|
26.2 percent
n=20 Participants
|
26.6 percent
n=40 Participants
|
|
Visceral Fat Percent
|
6 percent
n=20 Participants
|
5 percent
n=20 Participants
|
5.5 percent
n=40 Participants
|
|
The International Physical Activity Questionnaire, Long Form (27-item self-reported measure)
|
3003 total minutes of physical activity
n=20 Participants
|
1617 total minutes of physical activity
n=20 Participants
|
2310 total minutes of physical activity
n=40 Participants
|
PRIMARY outcome
Timeframe: The next table shows the distribution of the 13 domains of the Kujala´Test by intervention group at baseline (Time point 1, one day before intervention). "Assessed at baseline and after treatment, only baseline pre-specified to be reported".Population: Group A (core, hip and knee) completed a 28 exercises and Group B (hip and knee) completed a 24 exercises both groups during 8 weeks, each exercise session lasted 45 to 60 minutes and included warm up, strengthening, balance and stretching.
The Kujala patellofemoral pain scale, is an assessment tool developed to assesses pain and function in patients with disorders of the patellofemoral joint and consists of 13 questions, each with three to five response options, scored from 0 to 5, or 0 to 10, depending on the question. The lowest possible total value is 0 and corresponds to patients who are in a worse functional health condition. The highest possible total value is 100, for those that do not have any alteration and are in optimal condition. The results below, are presented as percentages and 95% confidence interval.
Outcome measures
| Measure |
Core, Hip and Knee.
n=20 Participants
Physical Exercises to strengthen the core, hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Hip and Knee
n=20 Participants
Physical Exercises to strengthen the hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
|---|---|---|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with constant and severe pain
|
20 percentage of participants
Interval 7.2 to 44.3
|
20 percentage of participants
Interval 7.2 to 44.3
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with occasional severe pain
|
20 percentage of participants
Interval 7.2 to 44.3
|
40 percentage of participants
Interval 20.5 to 63.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with pain that interferes with sleep
|
10 percentage of participants
Interval 2.31 to 34.2
|
10 percentage of participants
Interval 2.31 to 34.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with mild and occasional pain
|
50 percentage of participants
Interval 28.3 to 71.6
|
30 percentage of participants
Interval 13.4 to 54.1
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with permanent inflammation
|
10 percentage of participants
Interval 2.31 to 34.2
|
20 percentage of participants
Interval 7.2 to 44.3
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with inflammation every night
|
15 percentage of participants
Interval 4.5 to 39.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with inflammation with daily activities
|
30 percentage of participants
Interval 13.4 to 54.1
|
10 percentage of participants
Interval 2.31 to 34.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with inflammation after a great effort
|
30 percentage of participants
Interval 13.4 to 54.1
|
30 percentage of participants
Interval 13.4 to 54.1
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with not inflammation
|
15 percentage of participants
Interval 4.5 to 39.2
|
40 percentage of participants
Interval 20.5 to 63.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with severe atrophy
|
0 percentage of participants
Interval 0.0 to 0.0
|
5 percentage of participants
Interval 0.6 to 30.6
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with mild atrophy
|
15 percentage of participants
Interval 4.5 to 39.2
|
30 percentage of participants
Interval 13.4 to 54.1
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with not atrophy
|
85 percentage of participants
Interval 60.7 to 95.4
|
70 percentage of participants
Interval 45.8 to 86.5
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with lameness constantly
|
10 percentage of participants
Interval 2.31 to 34.2
|
10 percentage of participants
Interval 2.31 to 34.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with lameness a little, sometimes
|
80 percentage of participants
Interval 55.6 to 92.7
|
75 percentage of participants
Interval 50.6 to 89.7
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with no limp
|
10 percentage of participants
Interval 2.31 to 34.2
|
15 percentage of participants
Interval 4.59 to 39.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with impossible to support the limb
|
10 percentage of participants
Interval 2.31 to 34.2
|
5 percentage of participants
Interval 0.6 to 30.6
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with pain with limb support
|
55 percentage of participants
Interval 32.4 to 75.6
|
80 percentage of participants
Interval 55.6 to 92.7
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with the extremity completely painless
|
35 percentage of participants
Interval 16.9 to 58.7
|
15 percentage of participants
Interval 4.59 to 39.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that can't walk
|
5 percentage of participants
Interval 0.6 to 30.6
|
5 percentage of participants
Interval 0.6 to 30.6
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that can walk between 1-2 Km
|
20 percentage of participants
Interval 7.2 to 44.3
|
25 percentage of participants
Interval 10.2 to 49.3
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that can walk more than 2 km
|
45 percentage of participants
Interval 24.3 to 67.5
|
45 percentage of participants
Interval 24.3 to 67.5
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that can walk without limit
|
30 percentage of participants
Interval 13.4 to 54.1
|
25 percentage of participants
Interval 10.2 to 49.3
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that are not able to go up and down stairs
|
5 percentage of participants
Interval 0.6 to 30.6
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with pain when going up and down the stairs
|
50 percentage of participants
Interval 28.3 to 71.6
|
75 percentage of participants
Interval 54.9 to 95.0
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with slight pain when going down the stairs
|
45 percentage of participants
Interval 24.3 to 67.5
|
15 percentage of participants
Interval 4.59 to 39.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that can go up and down the stairs without difficulty
|
0 percentage of participants
Interval 0.0 to 0.0
|
10 percentage of participants
Interval 2.31 to 34.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that can't do squats
|
20 percentage of participants
Interval 7.2 to 44.39
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that can do squats with help
|
5 percentage of participants
Interval 0.6 to 30.6
|
15 percentage of participants
Interval 4.59 to 39.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that are always in pain when doing squats
|
20 percentage of participants
Interval 0.6 to 30.6
|
40 percentage of participants
Interval 20.5 to 63.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with pain when doing squats quickly
|
25 percentage of participants
Interval 7.26 to 44.39
|
40 percentage of participants
Interval 20.5 to 63.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants squating without difficulty
|
30 percentage of participants
Interval 13.4 to 54.1
|
5 percentage of participants
Interval 0.6 to 30.6
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants unable to remain seated with knees bent
|
15 percentage of participants
Interval 4.59 to 39.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with pain forces him/her to extend his knees
|
65 percentage of participants
Interval 41.2 to 83.0
|
70 percentage of participants
Interval 45.8 to 86.5
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that are always in pain to sit with their knees bent
|
10 percentage of participants
Interval 2.31 to 34.2
|
10 percentage of participants
Interval 2.31 to 34.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with only pain if they have exercised
|
5 percentage of participants
Interval 0.6 to 30.6
|
20 percentage of participants
Interval 7.26 to 44.3
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with no problem sitting with their knees bent
|
5 percentage of participants
Interval 0.6 to 30.6
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with more than two dislocations of the patella
|
10 percentage of participants
Interval 2.31 to 34.2
|
10 percentage of participants
Interval 2.31 to 34.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with less than a confirmed dislocation
|
10 percentage of participants
Interval 2.31 to 34.2
|
15 percentage of participants
Interval 4.59 to 39.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with dislocations occasionally with daily activities
|
20 percentage of participants
Interval 7.26 to 44.36
|
40 percentage of participants
Interval 20.5 to 63.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with dislocations occasionally with exercise
|
30 percentage of participants
Interval 13.4 to 54.1
|
30 percentage of participants
Interval 13.4 to 54.1
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with no dislocations of the patella
|
30 percentage of participants
Interval 13.4 to 54.1
|
5 percentage of participants
Interval 0.6 to 30.6
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with severe deficiency for knee flexion
|
20 percentage of participants
Interval 7.26 to 44.3
|
5 percentage of participants
Interval 0.6 to 30.6
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with mild deficiency for knee flexion
|
70 percentage of participants
Interval 45.8 to 86.5
|
70 percentage of participants
Interval 45.8 to 86.5
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with no deficiency for knee flexion
|
10 percentage of participants
Interval 2.31 to 34.2
|
25 percentage of participants
Interval 10.2 to 49.3
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants unable to run
|
25 percentage of participants
Interval 10.2 to 49.3
|
15 percentage of participants
Interval 4.59 to 39.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with severe pain always when running
|
0 percentage of participants
Interval 0.0 to 0.0
|
15 percentage of participants
Interval 4.59 to 39.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with slight pain since starting to run
|
25 percentage of participants
Interval 10.2 to 49.3
|
25 percentage of participants
Interval 10.2 to 49.3
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with pain after 2 km of running
|
35 percentage of participants
Interval 16.9 to 58.7
|
35 percentage of participants
Interval 16.9 to 58.7
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants that can run without limit
|
15 percentage of participants
Interval 4.59 to 39.2
|
10 percentage of participants
Interval 2.31 to 34.2
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants unable to jump
|
25 percentage of participants
Interval 10.2 to 49.3
|
30 percentage of participants
Interval 13.4 to 54.1
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with permanent pain when jumping
|
15 percentage of participants
Interval 4.59 to 39.2
|
20 percentage of participants
Interval 7.26 to 44.3
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with slight difficulty jumping
|
35 percentage of participants
Interval 16.9 to 58.7
|
35 percentage of participants
Interval 16.9 to 58.7
|
|
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
Percentage of participants with no difficulty jumping
|
25 percentage of participants
Interval 10.2 to 49.3
|
15 percentage of participants
Interval 4.59 to 39.2
|
PRIMARY outcome
Timeframe: The pain assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)Visual Analogue Scale (VAS) is a numeric scale from 0 to 10 to measure pain (been 0 no pain and 10 worse pain).
Outcome measures
| Measure |
Core, Hip and Knee.
n=20 Participants
Physical Exercises to strengthen the core, hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Hip and Knee
n=20 Participants
Physical Exercises to strengthen the hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
|---|---|---|
|
Assessment of Change in Pain With Visual Analogue Scale
Initial VAS
|
7.5 units on a scale
Interval 5.5 to 9.0
|
7 units on a scale
Interval 5.5 to 8.5
|
|
Assessment of Change in Pain With Visual Analogue Scale
Final VAS
|
2.0 units on a scale
Interval 0.0 to 2.0
|
2.0 units on a scale
Interval 0.0 to 4.0
|
|
Assessment of Change in Pain With Visual Analogue Scale
Delta (Change between Initial and Final VAS)
|
-6.0 units on a scale
Interval -10.0 to -4.0
|
-4.0 units on a scale
Interval -7.0 to -3.0
|
SECONDARY outcome
Timeframe: The Q angle assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention).We measured the Q angle (degrees) between the border of the anterosuperior iliac spine, the center of the patella and the center of the tibia. the data result, shows the median values, and the interquartile range (IR) with a Delta change between measure number 1 and number 2.
Outcome measures
| Measure |
Core, Hip and Knee.
n=20 Participants
Physical Exercises to strengthen the core, hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Hip and Knee
n=20 Participants
Physical Exercises to strengthen the hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
|---|---|---|
|
Change in Patellofemoral Misalignment With Q Angle´s Exam
Initial Rigth Knee
|
19 Degrees
Interval 15.0 to 20.0
|
18 Degrees
Interval 15.0 to 20.0
|
|
Change in Patellofemoral Misalignment With Q Angle´s Exam
Final Rigth Knee
|
18 Degrees
Interval 15.0 to 20.0
|
18 Degrees
Interval 15.0 to 20.0
|
|
Change in Patellofemoral Misalignment With Q Angle´s Exam
Delta or change between Time point 1 and 2
|
0 Degrees
Interval -2.0 to 2.0
|
0 Degrees
Interval -2.0 to 2.0
|
|
Change in Patellofemoral Misalignment With Q Angle´s Exam
Initial Left Knee
|
18 Degrees
Interval 15.0 to 20.0
|
18 Degrees
Interval 15.0 to 20.0
|
|
Change in Patellofemoral Misalignment With Q Angle´s Exam
Final Left Knee
|
18 Degrees
Interval 16.0 to 20.0
|
18 Degrees
Interval 15.0 to 20.0
|
|
Change in Patellofemoral Misalignment With Q Angle´s Exam
Delta or Change between Time point 1 and 2
|
0 Degrees
Interval -2.0 to 2.0
|
0 Degrees
Interval -2.0 to 2.0
|
SECONDARY outcome
Timeframe: The Core strength assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)The protocol consists of 3 tests that measure all aspects of torso strength via isometric muscle endurance 1.Trunk flexor test, 2.Trunk extensor test 3. Lateral musculature test (rigth and left side). t is a timed test involving a static, isometric contraction, until the individual exhibits fatigue and can no longer hold the assumed position. The goal of the test is to hold each position for as long as possible.
Outcome measures
| Measure |
Core, Hip and Knee.
n=20 Participants
Physical Exercises to strengthen the core, hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Hip and Knee
n=20 Participants
Physical Exercises to strengthen the hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
|---|---|---|
|
Change in Core Strength With McGill´s Exam
Plank (Time Point 1)
|
20.5 seconds
Interval 12.0 to 32.0
|
30 seconds
Interval 13.5 to 33.5
|
|
Change in Core Strength With McGill´s Exam
Plank (Time Point 2)
|
60 seconds
Interval 45.0 to 70.0
|
35 seconds
Interval 20.0 to 60.0
|
|
Change in Core Strength With McGill´s Exam
Plank: Delta or change between Time point 1 and 2
|
37 seconds
Interval 24.0 to 48.0
|
10 seconds
Interval 2.0 to 15.0
|
|
Change in Core Strength With McGill´s Exam
Lateral Plank (Right) (Time Point 1)
|
15 seconds
Interval 10.0 to 21.0
|
15 seconds
Interval 9.5 to 20.0
|
|
Change in Core Strength With McGill´s Exam
Lateral Plank (Right) (Time Point 2)
|
45 seconds
Interval 38.0 to 51.0
|
22 seconds
Interval 16.0 to 38.0
|
|
Change in Core Strength With McGill´s Exam
Rigth Lateral Plank: Delta or change between Time point 1 and 2
|
30 seconds
Interval 19.0 to 36.0
|
6 seconds
Interval 2.0 to 12.0
|
|
Change in Core Strength With McGill´s Exam
Lateral Plank (Left) (Time Point 1)
|
12.5 seconds
Interval 10.5 to 19.0
|
18 seconds
Interval 11.0 to 23.0
|
|
Change in Core Strength With McGill´s Exam
Lateral Plank (Left) (Time Point 2)
|
45 seconds
Interval 36.0 to 56.0
|
21 seconds
Interval 15.0 to 34.0
|
|
Change in Core Strength With McGill´s Exam
Left Lateral Plank: Delta or change between Time point 1 and 2
|
30 seconds
Interval 17.0 to 40.0
|
5 seconds
Interval -2.0 to 10.0
|
|
Change in Core Strength With McGill´s Exam
Trunk Extension (Time Point 1)
|
13.5 seconds
Interval 6.0 to 26.5
|
13.5 seconds
Interval 2.5 to 20.0
|
|
Change in Core Strength With McGill´s Exam
Trunk Extension (Time Point 2)
|
61 seconds
Interval 50.0 to 75.0
|
30 seconds
Interval 15.0 to 60.0
|
|
Change in Core Strength With McGill´s Exam
Trunk Extension: Delta or change between Time point 1 and 2
|
49 seconds
Interval 30.0 to 55.0
|
15 seconds
Interval 7.0 to 34.0
|
SECONDARY outcome
Timeframe: Quadriceps and gluteus Strength assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)Squat Test is a field test, easy and simple to assess the Gluteus and quadriceps muscles strength.
Outcome measures
| Measure |
Core, Hip and Knee.
n=20 Participants
Physical Exercises to strengthen the core, hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Hip and Knee
n=20 Participants
Physical Exercises to strengthen the hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
|---|---|---|
|
Change in Quadriceps and Gluteus Strength With Squat´s Test
Squats (Time Point 1)
|
10 seconds
Interval 8.0 to 18.5
|
12.5 seconds
Interval 8.5 to 20.0
|
|
Change in Quadriceps and Gluteus Strength With Squat´s Test
Squats (Time point 2)
|
35 seconds
Interval 30.0 to 38.0
|
35 seconds
Interval 29.0 to 38.0
|
|
Change in Quadriceps and Gluteus Strength With Squat´s Test
Delta or Change (Between Time 1 and 2)
|
20 seconds
Interval 18.0 to 25.0
|
20 seconds
Interval 15.0 to 24.0
|
SECONDARY outcome
Timeframe: Static Balance assesment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)This test is used to evaluate the control of postural and static balance with the eyes open and closed in seconds. (if the participant does not complete the 45 seconds framework is thought to be lacking of equilibrium).
Outcome measures
| Measure |
Core, Hip and Knee.
n=20 Participants
Physical Exercises to strengthen the core, hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Hip and Knee
n=20 Participants
Physical Exercises to strengthen the hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
|---|---|---|
|
Change in Static Balance With Single Leg Stance
Initial Balance with eyes open (Right leg)
|
11.5 seconds
Interval 0.0 to 25.5
|
7.5 seconds
Interval 0.0 to 30.0
|
|
Change in Static Balance With Single Leg Stance
Final Balance with eyes open (Right leg)
|
45 seconds
Interval 45.0 to 45.0
|
45 seconds
Interval 45.0 to 45.0
|
|
Change in Static Balance With Single Leg Stance
Balance with eyes open (Right leg): Delta or change between Time point 1 and 2
|
11.5 seconds
Interval 0.0 to 25.5
|
7.5 seconds
Interval 0.0 to 30.0
|
|
Change in Static Balance With Single Leg Stance
Initial Balance with eyes open (Left leg)
|
9.5 seconds
Interval 0.0 to 21.5
|
20 seconds
Interval 0.0 to 30.0
|
|
Change in Static Balance With Single Leg Stance
Final Balance with eyes open (Left leg)
|
45 seconds
Interval 45.0 to 45.0
|
45 seconds
Interval 45.0 to 45.0
|
|
Change in Static Balance With Single Leg Stance
Balance with eyes open (Left leg): Delta or change between time point 1 and 2
|
9.5 seconds
Interval 0.0 to 21.5
|
20 seconds
Interval 0.0 to 30.0
|
|
Change in Static Balance With Single Leg Stance
Initial Balance with eyes closed (Right leg)
|
20 seconds
Interval 14.0 to 27.5
|
19 seconds
Interval 9.5 to 24.0
|
|
Change in Static Balance With Single Leg Stance
Final Balance with eyes closed (Right leg)
|
28.5 seconds
Interval 21.0 to 35.0
|
23.5 seconds
Interval 16.5 to 31.5
|
|
Change in Static Balance With Single Leg Stance
Balance with eyes closed (Right leg): Delta or change between time point 1 and 2
|
20 seconds
Interval 14.0 to 27.5
|
19 seconds
Interval 9.5 to 24.0
|
|
Change in Static Balance With Single Leg Stance
Initial Balance with eyes closed (Left leg)
|
24.5 seconds
Interval 13.0 to 30.5
|
20 seconds
Interval 10.5 to 30.5
|
|
Change in Static Balance With Single Leg Stance
Final Balance with eyes closed (Left leg)
|
30 seconds
Interval 23.5 to 38.0
|
20 seconds
Interval 10.5 to 30.5
|
|
Change in Static Balance With Single Leg Stance
Balance with eyes closed (Left leg): Delta or change between time point 1 and 2
|
24.5 seconds
Interval 13.0 to 30.5
|
20 seconds
Interval 10.5 to 30.5
|
SECONDARY outcome
Timeframe: Physical Activity will be measured at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)The amount of physical activity places patients in 1 to 3 categories: 1\. Low/inactive: do not meet criteria for categories 2 or 3. 2. Moderate: meet 1 the following: a. 3 or more days with at least 20 minutes of vigorous activity b. 5 or more days with at least 30 minutes of moderate-intensity activity or walking. c. 5 or more days with any combination of walking, moderate-intensity, or vigorous intensity activities with at least 600 MET-min/week. 3. High: meet 1 of the following: a. 3 or more days of vigorous-intensity activity and at least 1500 MET-min/week. b. 7 days of any combination of walking moderate-intensity, or vigorous intensity activities with at least 3000 MET-min/week. We decided to add the time in minutes for each category of the IPAQ (work, transport, home and recreation), to obtain a more objective calculation, and to be able to make comparisons between the two different time points.
Outcome measures
| Measure |
Core, Hip and Knee.
n=20 Participants
Physical Exercises to strengthen the core, hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
Hip and Knee
n=20 Participants
Physical Exercises to strengthen the hip and knee.
Strengthening program: Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
Group A: 28 exercises Group B: 24 exercises
|
|---|---|---|
|
Change in the Total Amount (Work, Transport, Home and Recreation) of Physical Activity Reported in Minutes and Measured With The International Physical Activity Questionnaire-Long Form
Initial IPAQ Total Minutes
|
3003 minutes
Interval 1116.0 to 4638.0
|
1617 minutes
Interval 944.0 to 6138.0
|
|
Change in the Total Amount (Work, Transport, Home and Recreation) of Physical Activity Reported in Minutes and Measured With The International Physical Activity Questionnaire-Long Form
Final IPAQ Total Minutes
|
4275 minutes
Interval 2587.0 to 6522.0
|
4598 minutes
Interval 2888.0 to 7344.0
|
|
Change in the Total Amount (Work, Transport, Home and Recreation) of Physical Activity Reported in Minutes and Measured With The International Physical Activity Questionnaire-Long Form
Delta or change between Time point 1 and 2
|
1539 minutes
Interval 807.0 to 2457.0
|
1977 minutes
Interval 1191.0 to 2815.0
|
Adverse Events
Core, Hip and Knee.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hip and Knee
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place