Trial Outcomes & Findings for Exercise Therapy Program in Ankylosing Spondylitis Patients (NCT NCT01690273)
NCT ID: NCT01690273
Last Updated: 2016-10-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Baseline and 16 Weeks
Results posted on
2016-10-20
Participant Flow
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
Seventy patients did not accepted and 84 did not followed inclusion criteria. Fifty five were allocated into three groups after following the inclusion criteria.
Participant milestones
| Measure |
Ankylosing Spondylitis Control
control group, no intervention in ankylosing spondylitis patients
|
Mobility in Ankylosing Spondylitis
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility and Elastic Resistance Exercise in AS
mobility, plus elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
20
|
|
Overall Study
COMPLETED
|
18
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Therapy Program in Ankylosing Spondylitis Patients
Baseline characteristics by cohort
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
|
Stretching in AS
n=17 Participants
stretching exercises
stretching exercise: 30 minutes, twice a week for sixteen weeks.
|
Elastic Resistance Exercise in AS
n=20 Participants
stretching and elastic resistance exercises
stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
FUNCTIONAL INDEX
baseline
|
3.4 units on a scale
Standard Deviation 2.7
|
4.3 units on a scale
Standard Deviation 1.9
|
3.2 units on a scale
Standard Deviation 2.6
|
|
FUNCTIONAL INDEX
16 weeks
|
4.5 units on a scale
Standard Deviation 2.5
|
4.0 units on a scale
Standard Deviation 2.2
|
2.2 units on a scale
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Baseline 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)
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Mobility Index
baseline
|
4.3 units on a scale from 0 to 10
Standard Deviation 2
|
5.3 units on a scale from 0 to 10
Standard Deviation 2
|
4.5 units on a scale from 0 to 10
Standard Deviation 2.1
|
|
Mobility Index
16 weeks
|
4.6 units on a scale from 0 to 10
Standard Deviation 2.0
|
4.8 units on a scale from 0 to 10
Standard Deviation 2.1
|
4.0 units on a scale from 0 to 10
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline 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)
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Disease Activity Index
baseline
|
2 units on a scale
Standard Deviation 1
|
2.6 units on a scale
Standard Deviation 1.1
|
2.1 units on a scale
Standard Deviation 1.4
|
|
Disease Activity Index
16 weeks
|
3.2 units on a scale
Standard Deviation 2.0
|
2.9 units on a scale
Standard Deviation 1.4
|
1.7 units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline 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
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Ankylosing Spondylitis Disease Activity Scale -Disease Activity
baseline
|
1.8 units on a scale
Standard Deviation 0.7
|
1.7 units on a scale
Standard Deviation 0.7
|
1.5 units on a scale
Standard Deviation 0.7
|
|
Ankylosing Spondylitis Disease Activity Scale -Disease Activity
16 weeks
|
2.2 units on a scale
Standard Deviation 0.8
|
1.6 units on a scale
Standard Deviation 0.7
|
1.4 units on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Global Evaluation Self Reported
baseline
|
3.6 units on a scale
Standard Deviation 1.9
|
5.0 units on a scale
Standard Deviation 2.3
|
4.1 units on a scale
Standard Deviation 2.6
|
|
Global Evaluation Self Reported
16 weeks
|
5.6 units on a scale
Standard Deviation 2.4
|
4.7 units on a scale
Standard Deviation 2.2
|
3.4 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and 16 WeeksThoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Thoracolumbar Mobility
baseline
|
1.9 Centimeters
Standard Deviation 1.5
|
1.4 Centimeters
Standard Deviation 0.9
|
1.6 Centimeters
Standard Deviation 1.1
|
|
Thoracolumbar Mobility
16 weeks
|
1.7 Centimeters
Standard Deviation 0.9
|
2.1 Centimeters
Standard Deviation 1.0
|
2.6 Centimeters
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Pain Scale
baseline
|
1.8 units on a scale
Standard Deviation 1.8
|
2.5 units on a scale
Standard Deviation 1.9
|
2.0 units on a scale
Standard Deviation 1.9
|
|
Pain Scale
16 weeks
|
2.3 units on a scale
Standard Deviation 2.7
|
2.4 units on a scale
Standard Deviation 1.5
|
2.0 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Stiffness Scale
baseline
|
3.1 units on a scale
Standard Deviation 2.6
|
3.1 units on a scale
Standard Deviation 2.2
|
3.1 units on a scale
Standard Deviation 2.4
|
|
Stiffness Scale
16 weeks
|
4.3 units on a scale
Standard Deviation 2.6
|
4.2 units on a scale
Standard Deviation 2.0
|
2.8 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Short Form-12 (PCS)
baseline
|
42.3 units on a scale
Standard Deviation 7.4
|
38.8 units on a scale
Standard Deviation 8.0
|
43.9 units on a scale
Standard Deviation 8.5
|
|
Short Form-12 (PCS)
16 weeks
|
41.9 units on a scale
Standard Deviation 8.8
|
40.9 units on a scale
Standard Deviation 10.6
|
44.8 units on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Short Form-12 (MCS)
baseline
|
51.8 units on a scale
Standard Deviation 10.7
|
45.7 units on a scale
Standard Deviation 11.6
|
47.1 units on a scale
Standard Deviation 13.5
|
|
Short Form-12 (MCS)
16 weeks
|
52.1 units on a scale
Standard Deviation 9.7
|
46.0 units on a scale
Standard Deviation 10.8
|
51.6 units on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline 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
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
MASES
baseline
|
0.7 Number of painful tender points
Standard Deviation 1.4
|
1.5 Number of painful tender points
Standard Deviation 3.4
|
0.8 Number of painful tender points
Standard Deviation 1.7
|
|
MASES
16 weeks
|
1.3 Number of painful tender points
Standard Deviation 1.9
|
1.1 Number of painful tender points
Standard Deviation 1.7
|
0.7 Number of painful tender points
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline 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
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Chin-coronoid Distance
baseline
|
9.9 Centimeters
Standard Deviation 2.7
|
14.2 Centimeters
Standard Deviation 5.6
|
10.9 Centimeters
Standard Deviation 3.6
|
|
Chin-coronoid Distance
16 weeks
|
10.0 Centimeters
Standard Deviation 2.5
|
9.5 Centimeters
Standard Deviation 2.3
|
9.2 Centimeters
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline 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
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Tragus-coronoid Distance
baseline
|
9.9 Centimeters
Standard Deviation 2.7
|
12.3 Centimeters
Standard Deviation 4.0
|
9.7 Centimeters
Standard Deviation 3.3
|
|
Tragus-coronoid Distance
16 weeks
|
10.1 Centimeters
Standard Deviation 2.2
|
9.0 Centimeters
Standard Deviation 2.0
|
8.8 Centimeters
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline 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
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Finger Floor Distance
baseline
|
27.6 Centimeters
Standard Deviation 13.3
|
27.1 Centimeters
Standard Deviation 13.7
|
23.7 Centimeters
Standard Deviation 12.0
|
|
Finger Floor Distance
16 weeks
|
29.5 Centimeters
Standard Deviation 13.6
|
24.2 Centimeters
Standard Deviation 13.3
|
20.3 Centimeters
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Ankylosing Spondylitis Control
n=18 Participants
control group with AS patients and no exercise
|
Mobility in AS
n=17 Participants
mobility exercises
mobility exercise: 30 minutes, twice a week
|
Mobility Plus Elastic Resistance Exercise in AS
n=20 Participants
mobility and elastic resistance exercises
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)
|
|---|---|---|---|
|
Chest Expansion
baseline
|
2.8 Centimeters
Standard Deviation 1.3
|
2.8 Centimeters
Standard Deviation 1.2
|
3.6 Centimeters
Standard Deviation 1.7
|
|
Chest Expansion
16 weeks
|
3.0 Centimeters
Standard Deviation 1.9
|
3.3 Centimeters
Standard Deviation 1.2
|
4.3 Centimeters
Standard Deviation 1.9
|
Adverse Events
Ankylosing Spondylitis Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stretching in AS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Elastic Resistance Exercise in AS
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