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Exercise Therapy Program in Ankylosing Spondylitis Patients

Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01690273
Enrollment
55
Registered
2012-09-21
Start date
2012-07-31
Completion date
2014-11-30
Last updated
2016-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

exercise, mobility, strengthening, physiotherapy

Brief summary

Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore axial mobility, but there are no data regarding a specific rehabilitation program that includes flexibility alone and its association with resistance exercises in AS patients with stable disease activity. So, we assessed the effects of two exercise programs in terms of mobility, functional capacity, quality of life and disease activity in AS patients. Methods. Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI) \<4 were included.

Detailed description

The AS patients were randomly assigned into three groups, to receive a mobility exercise program (M) or mobility plus elastic resistance exercise program (M+R) or no exercise (C). The exercises group sessions were conducted twice per week for 16 weeks. This supervised program comprised 30 minutes of outdoor stretching and mobility exercises for the spine and limbs (M). After the flexibility program, M+R group carry out more 30 minutes of elastic resistance exercises. The mobility, disease activity and functional parameters were evaluated at baseline and after 16 weeks, with the evaluator blinded to the treatment group.

Interventions

OTHERmobility exercise

30 minutes, twice a week

OTHERmobility and elastic resistance exercise

30 minutes, twice a week each exercises group. (total 1 hour)

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Ankylosing spondylitis patient * Basdai index lower than 4 * Physical inactive * Functional class I to III

Exclusion criteria

* Fibromyalgia * Cardiovascular disease * Pain Visual Analogue Scale (VAS) over 8

Design outcomes

Primary

MeasureTime frameDescription
FUNCTIONAL INDEXBaseline and 16 WeeksBASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.
Mobility IndexBaseline and 16 weeksBath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)
Disease Activity IndexBaseline and 16 WeeksBASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)
Ankylosing Spondylitis Disease Activity Scale -Disease ActivityBaseline and 16 WeeksScores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD
Global Evaluation Self ReportedBaseline and 16 WeeksBath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.

Secondary

MeasureTime frameDescription
Thoracolumbar MobilityBaseline and 16 WeeksThoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
Pain ScaleBaseline and 16 WeeksPain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.
Stiffness ScaleBaseline and 16 WeeksStiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.
Short Form-12 (PCS)Baseline and 16 WeeksQuality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.
Short Form-12 (MCS)Baseline and 16 WeeksQuality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.
MASESBaseline and 16 WeeksMaastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation
Chin-coronoid DistanceBaseline and 16 Weekslateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation
Tragus-coronoid DistanceBaseline and 16 Weekslateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation
Finger Floor DistanceBaseline and 16 WeeksDistance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation
Chest ExpansionBaseline and 16 WeeksChest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.

Countries

Brazil

Participant flow

Recruitment details

Two hundred nine consecutive patients from the division of rheumatology outpatient clinic of the university hospital (Clinics Hospital of University Medicine School of Sao Paulo) diagnosed with AS according to the modified New York criteria, were invited to participate. Fifty Five individuals were randomly allocated into three groups

Pre-assignment details

Seventy patients did not accepted and 84 did not followed inclusion criteria. Fifty five were allocated into three groups after following the inclusion criteria.

Participants by arm

ArmCount
Ankylosing Spondylitis Control
Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
18
Stretching in AS
stretching exercises stretching exercise: 30 minutes, twice a week for sixteen weeks.
17
Elastic Resistance Exercise in AS
stretching and elastic resistance exercises stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks.
20
Total55

Baseline characteristics

CharacteristicAnkylosing Spondylitis ControlStretching in ASElastic Resistance Exercise in ASTotal
Age, Continuous47.1 years
STANDARD_DEVIATION 10.8
49.2 years
STANDARD_DEVIATION 13.1
48.3 years
STANDARD_DEVIATION 11.1
48.2 years
STANDARD_DEVIATION 11.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
5 Participants5 Participants7 Participants17 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
13 Participants12 Participants13 Participants38 Participants
Sex: Female, Male
Female
3 Participants2 Participants2 Participants7 Participants
Sex: Female, Male
Male
15 Participants15 Participants18 Participants48 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 180 / 170 / 20
serious
Total, serious adverse events
0 / 180 / 170 / 20

Outcome results

Primary

Ankylosing Spondylitis Disease Activity Scale -Disease Activity

Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlAnkylosing Spondylitis Disease Activity Scale -Disease Activitybaseline1.8 units on a scaleStandard Deviation 0.7
Ankylosing Spondylitis ControlAnkylosing Spondylitis Disease Activity Scale -Disease Activity16 weeks2.2 units on a scaleStandard Deviation 0.8
Mobility in ASAnkylosing Spondylitis Disease Activity Scale -Disease Activitybaseline1.7 units on a scaleStandard Deviation 0.7
Mobility in ASAnkylosing Spondylitis Disease Activity Scale -Disease Activity16 weeks1.6 units on a scaleStandard Deviation 0.7
Mobility Plus Elastic Resistance Exercise in ASAnkylosing Spondylitis Disease Activity Scale -Disease Activitybaseline1.5 units on a scaleStandard Deviation 0.7
Mobility Plus Elastic Resistance Exercise in ASAnkylosing Spondylitis Disease Activity Scale -Disease Activity16 weeks1.4 units on a scaleStandard Deviation 0.7
p-value: 0.09Mixed Models Analysis
p-value: 0.99Mixed Models Analysis
p-value: 0.94Mixed Models Analysis
p-value: 0.213Mixed Models Analysis
p-value: 0.007Mixed Models Analysis
p-value: 0.9Mixed Models Analysis
Primary

Disease Activity Index

BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlDisease Activity Index16 weeks3.2 units on a scaleStandard Deviation 2
Ankylosing Spondylitis ControlDisease Activity Indexbaseline2 units on a scaleStandard Deviation 1
Mobility in ASDisease Activity Indexbaseline2.6 units on a scaleStandard Deviation 1.1
Mobility in ASDisease Activity Index16 weeks2.9 units on a scaleStandard Deviation 1.4
Mobility Plus Elastic Resistance Exercise in ASDisease Activity Indexbaseline2.1 units on a scaleStandard Deviation 1.4
Mobility Plus Elastic Resistance Exercise in ASDisease Activity Index16 weeks1.7 units on a scaleStandard Deviation 1.4
p-value: 0.004Mixed Models Analysis
p-value: 0.87Mixed Models Analysis
p-value: 0.83Mixed Models Analysis
p-value: 0.989Mixed Models Analysis
p-value: 0.022Mixed Models Analysis
p-value: 0.119Mixed Models Analysis
Primary

FUNCTIONAL INDEX

BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlFUNCTIONAL INDEXbaseline3.4 units on a scaleStandard Deviation 2.7
Ankylosing Spondylitis ControlFUNCTIONAL INDEX16 weeks4.5 units on a scaleStandard Deviation 2.5
Mobility in ASFUNCTIONAL INDEXbaseline4.3 units on a scaleStandard Deviation 1.9
Mobility in ASFUNCTIONAL INDEX16 weeks4.0 units on a scaleStandard Deviation 2.2
Mobility Plus Elastic Resistance Exercise in ASFUNCTIONAL INDEXbaseline3.2 units on a scaleStandard Deviation 2.6
Mobility Plus Elastic Resistance Exercise in ASFUNCTIONAL INDEX16 weeks2.2 units on a scaleStandard Deviation 2
p-value: 0.13Mixed Models Analysis
p-value: 0.99Mixed Models Analysis
p-value: 0.11Mixed Models Analysis
p-value: 0.9913Mixed Models Analysis
p-value: 0.0427Mixed Models Analysis
p-value: 0.1856Mixed Models Analysis
Primary

Global Evaluation Self Reported

Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEDIAN)Dispersion
Ankylosing Spondylitis ControlGlobal Evaluation Self Reported16 weeks5.6 units on a scaleStandard Deviation 2.4
Ankylosing Spondylitis ControlGlobal Evaluation Self Reportedbaseline3.6 units on a scaleStandard Deviation 1.9
Mobility in ASGlobal Evaluation Self Reported16 weeks4.7 units on a scaleStandard Deviation 2.2
Mobility in ASGlobal Evaluation Self Reportedbaseline5.0 units on a scaleStandard Deviation 2.3
Mobility Plus Elastic Resistance Exercise in ASGlobal Evaluation Self Reportedbaseline4.1 units on a scaleStandard Deviation 2.6
Mobility Plus Elastic Resistance Exercise in ASGlobal Evaluation Self Reported16 weeks3.4 units on a scaleStandard Deviation 2.5
p-value: 0.003Mixed Models Analysis
p-value: 0.99Mixed Models Analysis
p-value: 0.69Mixed Models Analysis
p-value: 0.874Mixed Models Analysis
p-value: 0.057Mixed Models Analysis
p-value: 0.526Mixed Models Analysis
Primary

Mobility Index

Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)

Time frame: Baseline and 16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlMobility Indexbaseline4.3 units on a scale from 0 to 10Standard Deviation 2
Ankylosing Spondylitis ControlMobility Index16 weeks4.6 units on a scale from 0 to 10Standard Deviation 2
Mobility in ASMobility Indexbaseline5.3 units on a scale from 0 to 10Standard Deviation 2
Mobility in ASMobility Index16 weeks4.8 units on a scale from 0 to 10Standard Deviation 2.1
Mobility Plus Elastic Resistance Exercise in ASMobility Indexbaseline4.5 units on a scale from 0 to 10Standard Deviation 2.1
Mobility Plus Elastic Resistance Exercise in ASMobility Index16 weeks4.0 units on a scale from 0 to 10Standard Deviation 2.1
p-value: 0.04Mixed Models Analysis
p-value: 0.0002Mixed Models Analysis
p-value: 0.0002Mixed Models Analysis
p-value: 1Mixed Models Analysis
p-value: 0.935Mixed Models Analysis
p-value: 0.876Mixed Models Analysis
Secondary

Chest Expansion

Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlChest Expansionbaseline2.8 CentimetersStandard Deviation 1.3
Ankylosing Spondylitis ControlChest Expansion16 weeks3.0 CentimetersStandard Deviation 1.9
Mobility in ASChest Expansionbaseline2.8 CentimetersStandard Deviation 1.2
Mobility in ASChest Expansion16 weeks3.3 CentimetersStandard Deviation 1.2
Mobility Plus Elastic Resistance Exercise in ASChest Expansionbaseline3.6 CentimetersStandard Deviation 1.7
Mobility Plus Elastic Resistance Exercise in ASChest Expansion16 weeks4.3 CentimetersStandard Deviation 1.9
p-value: 0.978Mixed Models Analysis
p-value: 0.169Mixed Models Analysis
p-value: 0.002Mixed Models Analysis
p-value: 0.993Mixed Models Analysis
p-value: 0.105Mixed Models Analysis
p-value: 0.335Mixed Models Analysis
Secondary

Chin-coronoid Distance

lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlChin-coronoid Distancebaseline9.9 CentimetersStandard Deviation 2.7
Ankylosing Spondylitis ControlChin-coronoid Distance16 weeks10.0 CentimetersStandard Deviation 2.5
Mobility in ASChin-coronoid Distancebaseline14.2 CentimetersStandard Deviation 5.6
Mobility in ASChin-coronoid Distance16 weeks9.5 CentimetersStandard Deviation 2.3
Mobility Plus Elastic Resistance Exercise in ASChin-coronoid Distancebaseline10.9 CentimetersStandard Deviation 3.6
Mobility Plus Elastic Resistance Exercise in ASChin-coronoid Distance16 weeks9.2 CentimetersStandard Deviation 1.6
p-value: 1Mixed Models Analysis
p-value: 0Mixed Models Analysis
p-value: 0.35Mixed Models Analysis
p-value: 0.997Mixed Models Analysis
p-value: 0.97Mixed Models Analysis
p-value: 0.999Mixed Models Analysis
Secondary

Finger Floor Distance

Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlFinger Floor Distancebaseline27.6 CentimetersStandard Deviation 13.3
Ankylosing Spondylitis ControlFinger Floor Distance16 weeks29.5 CentimetersStandard Deviation 13.6
Mobility in ASFinger Floor Distancebaseline27.1 CentimetersStandard Deviation 13.7
Mobility in ASFinger Floor Distance16 weeks24.2 CentimetersStandard Deviation 13.3
Mobility Plus Elastic Resistance Exercise in ASFinger Floor Distancebaseline23.7 CentimetersStandard Deviation 12
Mobility Plus Elastic Resistance Exercise in ASFinger Floor Distance16 weeks20.3 CentimetersStandard Deviation 11.8
p-value: 0.787Mixed Models Analysis
p-value: 0.408Mixed Models Analysis
p-value: 0.157Mixed Models Analysis
p-value: 0.835Mixed Models Analysis
p-value: 0.256Mixed Models Analysis
p-value: 0.935Mixed Models Analysis
Secondary

MASES

Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlMASESbaseline0.7 Number of painful tender pointsStandard Deviation 1.4
Ankylosing Spondylitis ControlMASES16 weeks1.3 Number of painful tender pointsStandard Deviation 1.9
Mobility in ASMASESbaseline1.5 Number of painful tender pointsStandard Deviation 3.4
Mobility in ASMASES16 weeks1.1 Number of painful tender pointsStandard Deviation 1.7
Mobility Plus Elastic Resistance Exercise in ASMASESbaseline0.8 Number of painful tender pointsStandard Deviation 1.7
Mobility Plus Elastic Resistance Exercise in ASMASES16 weeks0.7 Number of painful tender pointsStandard Deviation 1.5
p-value: 0.8Mixed Models Analysis
p-value: 0.97Mixed Models Analysis
p-value: 0.99Mixed Models Analysis
p-value: 0.999Mixed Models Analysis
p-value: 0.929Mixed Models Analysis
p-value: 0.98Mixed Models Analysis
Secondary

Pain Scale

Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlPain Scalebaseline1.8 units on a scaleStandard Deviation 1.8
Ankylosing Spondylitis ControlPain Scale16 weeks2.3 units on a scaleStandard Deviation 2.7
Mobility in ASPain Scalebaseline2.5 units on a scaleStandard Deviation 1.9
Mobility in ASPain Scale16 weeks2.4 units on a scaleStandard Deviation 1.5
Mobility Plus Elastic Resistance Exercise in ASPain Scalebaseline2.0 units on a scaleStandard Deviation 1.9
Mobility Plus Elastic Resistance Exercise in ASPain Scale16 weeks2.0 units on a scaleStandard Deviation 1.9
p-value: 0.13Mixed Models Analysis
p-value: 0.07Mixed Models Analysis
p-value: 0.97Mixed Models Analysis
p-value: 1Mixed Models Analysis
p-value: 0.338Mixed Models Analysis
p-value: 0.476Mixed Models Analysis
Secondary

Short Form-12 (MCS)

Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlShort Form-12 (MCS)baseline51.8 units on a scaleStandard Deviation 10.7
Ankylosing Spondylitis ControlShort Form-12 (MCS)16 weeks52.1 units on a scaleStandard Deviation 9.7
Mobility in ASShort Form-12 (MCS)baseline45.7 units on a scaleStandard Deviation 11.6
Mobility in ASShort Form-12 (MCS)16 weeks46.0 units on a scaleStandard Deviation 10.8
Mobility Plus Elastic Resistance Exercise in ASShort Form-12 (MCS)baseline47.1 units on a scaleStandard Deviation 13.5
Mobility Plus Elastic Resistance Exercise in ASShort Form-12 (MCS)16 weeks51.6 units on a scaleStandard Deviation 12.4
p-value: 1Mixed Models Analysis
p-value: 1Mixed Models Analysis
p-value: 0.37Mixed Models Analysis
p-value: 0.618Mixed Models Analysis
p-value: 1Mixed Models Analysis
p-value: 0.689Mixed Models Analysis
Secondary

Short Form-12 (PCS)

Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlShort Form-12 (PCS)baseline42.3 units on a scaleStandard Deviation 7.4
Ankylosing Spondylitis ControlShort Form-12 (PCS)16 weeks41.9 units on a scaleStandard Deviation 8.8
Mobility in ASShort Form-12 (PCS)baseline38.8 units on a scaleStandard Deviation 8
Mobility in ASShort Form-12 (PCS)16 weeks40.9 units on a scaleStandard Deviation 10.6
Mobility Plus Elastic Resistance Exercise in ASShort Form-12 (PCS)baseline43.9 units on a scaleStandard Deviation 8.5
Mobility Plus Elastic Resistance Exercise in ASShort Form-12 (PCS)16 weeks44.8 units on a scaleStandard Deviation 8.8
p-value: 0.9Mixed Models Analysis
p-value: 0.7Mixed Models Analysis
p-value: 0.99Mixed Models Analysis
p-value: 0.999Mixed Models Analysis
p-value: 0.9Mixed Models Analysis
p-value: 0.739Mixed Models Analysis
Secondary

Stiffness Scale

Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlStiffness Scalebaseline3.1 units on a scaleStandard Deviation 2.6
Ankylosing Spondylitis ControlStiffness Scale16 weeks4.3 units on a scaleStandard Deviation 2.6
Mobility in ASStiffness Scalebaseline3.1 units on a scaleStandard Deviation 2.2
Mobility in ASStiffness Scale16 weeks4.2 units on a scaleStandard Deviation 2
Mobility Plus Elastic Resistance Exercise in ASStiffness Scalebaseline3.1 units on a scaleStandard Deviation 2.4
Mobility Plus Elastic Resistance Exercise in ASStiffness Scale16 weeks2.8 units on a scaleStandard Deviation 2
p-value: 0.88Mixed Models Analysis
p-value: 0.99Mixed Models Analysis
p-value: 1Mixed Models Analysis
p-value: 1Mixed Models Analysis
p-value: 0.995Mixed Models Analysis
p-value: 0.985Mixed Models Analysis
Secondary

Thoracolumbar Mobility

Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlThoracolumbar Mobilitybaseline1.9 CentimetersStandard Deviation 1.5
Ankylosing Spondylitis ControlThoracolumbar Mobility16 weeks1.7 CentimetersStandard Deviation 0.9
Mobility in ASThoracolumbar Mobilitybaseline1.4 CentimetersStandard Deviation 0.9
Mobility in ASThoracolumbar Mobility16 weeks2.1 CentimetersStandard Deviation 1
Mobility Plus Elastic Resistance Exercise in ASThoracolumbar Mobilitybaseline1.6 CentimetersStandard Deviation 1.1
Mobility Plus Elastic Resistance Exercise in ASThoracolumbar Mobility16 weeks2.6 CentimetersStandard Deviation 1.1
p-value: 0.853Mixed Models Analysis
p-value: 0.016Mixed Models Analysis
p-value: 0Mixed Models Analysis
p-value: 0.889Mixed Models Analysis
p-value: 0.098Mixed Models Analysis
p-value: 0.645Mixed Models Analysis
Secondary

Tragus-coronoid Distance

lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation

Time frame: Baseline and 16 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Ankylosing Spondylitis ControlTragus-coronoid Distancebaseline9.9 CentimetersStandard Deviation 2.7
Ankylosing Spondylitis ControlTragus-coronoid Distance16 weeks10.1 CentimetersStandard Deviation 2.2
Mobility in ASTragus-coronoid Distancebaseline12.3 CentimetersStandard Deviation 4
Mobility in ASTragus-coronoid Distance16 weeks9.0 CentimetersStandard Deviation 2
Mobility Plus Elastic Resistance Exercise in ASTragus-coronoid Distancebaseline9.7 CentimetersStandard Deviation 3.3
Mobility Plus Elastic Resistance Exercise in ASTragus-coronoid Distance16 weeks8.8 CentimetersStandard Deviation 2
p-value: 0.997Mixed Models Analysis
p-value: 0Mixed Models Analysis
p-value: 0.503Mixed Models Analysis
p-value: 0.814Mixed Models Analysis
p-value: 0.643Mixed Models Analysis
p-value: 0.999Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026