Trial Outcomes & Findings for Effectiveness of Dance on Patients With Fibromyalgia (NCT NCT00961805)

NCT ID: NCT00961805

Last Updated: 2009-08-25

Results Overview

score between 0 and 100 where 0 is no pain and 100 in unbearable pain

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: baseline, after 16 weeks and after 32 weeks
• Results posted on: 2009-08-25

Participant Flow

The recruitment of patients started in August 2007 and finished in April 2008. The recruitment was made in Sao Paulo Hospital division of Rheumatology

Participant milestones

Measure	Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Dance on Patients With Fibromyalgia

Baseline characteristics by cohort

Measure	Group Control n=40 Participants The waiting list	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	49.1 years STANDARD_DEVIATION 11.5 • n=5 Participants	49.5 years STANDARD_DEVIATION 10.9 • n=7 Participants	49.3 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 and 100 where 0 is no pain and 100 in unbearable pain

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Visual Analog Scale for Pain Baseline	75 mm Standard Deviation 13	75 mm Standard Deviation 17
Visual Analog Scale for Pain After 16 weeks	75 mm Standard Deviation 14	46 mm Standard Deviation 20
Visual Analog Scale for Pain After 32 weeks	73 mm Standard Deviation 17	47 mm Standard Deviation 26

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

meters traveled on a 20-meter course over a six-minute period

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Function - 6 Minute Walk Test Baseline	332 meters Standard Deviation 66.7	372.8 meters Standard Deviation 80.2
Function - 6 Minute Walk Test after 16 weeks	344.3 meters Standard Deviation 72.7	443.5 meters Standard Deviation 78.3
Function - 6 Minute Walk Test after 32 weeks	343 meters Standard Deviation 77.9	431 meters Standard Deviation 88.7

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Quality of Life - Fibromyalgia Impact Questionnaire Baseline	6.34 units on a scale Standard Deviation 1.29	5.89 units on a scale Standard Deviation 1.39
Quality of Life - Fibromyalgia Impact Questionnaire After 16 weeks	6.61 units on a scale Standard Deviation 1.53	4.69 units on a scale Standard Deviation 1.73
Quality of Life - Fibromyalgia Impact Questionnaire After 32 weeks	5.9 units on a scale Standard Deviation 1.86	4.26 units on a scale Standard Deviation 1.81

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 from 100, with higher scores denoting better quality of life

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Quality of Life - SF-36 -Functional Capacity Baseline	32.6 units on a scale Standard Deviation 18.9	44.9 units on a scale Standard Deviation 18.9
Quality of Life - SF-36 -Functional Capacity After 16 weeks	33.1 units on a scale Standard Deviation 18.6	52.9 units on a scale Standard Deviation 21.1
Quality of Life - SF-36 -Functional Capacity After 32 weeks	39.1 units on a scale Standard Deviation 22	56.3 units on a scale Standard Deviation 19.9

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 from 100, with higher scores denoting better quality of life

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Quality of Life - SF-36 - Physical Limitation Baseline	8.8 units on a scale Standard Deviation 17.9	24.7 units on a scale Standard Deviation 32.2
Quality of Life - SF-36 - Physical Limitation After 16 weeks	10.4 units on a scale Standard Deviation 21.6	40.5 units on a scale Standard Deviation 30.6
Quality of Life - SF-36 - Physical Limitation After 32 weeks	13.8 units on a scale Standard Deviation 26.5	36.5 units on a scale Standard Deviation 13.8

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 from 100, with higher scores denoting better quality of life

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Quality of Life - Sf-36 - Pain Baseline	25.7 units on a scale Standard Deviation 13.4	29.6 units on a scale Standard Deviation 17.5
Quality of Life - Sf-36 - Pain After 16 weeks	25.1 units on a scale Standard Deviation 14.2	44.7 units on a scale Standard Deviation 20.7
Quality of Life - Sf-36 - Pain After 32 weeks	29.1 units on a scale Standard Deviation 21.1	46 units on a scale Standard Deviation 19.2

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 from 100, with higher scores denoting better quality of life

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Quality of Life - Sf-36 - General Health State Baseline	38 units on a scale Standard Deviation 16.5	46 units on a scale Standard Deviation 21.7
Quality of Life - Sf-36 - General Health State After 16 weeks	38.1 units on a scale Standard Deviation 18.3	45 units on a scale Standard Deviation 21.3
Quality of Life - Sf-36 - General Health State After 32 weeks	41.5 units on a scale Standard Deviation 21.4	44.9 units on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 from 100, with higher scores denoting better quality of life

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Quality of Life - SF-36 - Vitality After 32 weeks	37.1 units on a scale Standard Deviation 21.8	47.6 units on a scale Standard Deviation 24.5
Quality of Life - SF-36 - Vitality Baseline	29 units on a scale Standard Deviation 18.2	41.3 units on a scale Standard Deviation 18.8
Quality of Life - SF-36 - Vitality After 16 weeks	30.7 units on a scale Standard Deviation 18.1	50 units on a scale Standard Deviation 22.8

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 from 100, with higher scores denoting better quality of life

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Quality of Life - SF-36 - Social Aspects Baseline	47.6 units on a scale Standard Deviation 23.1	52.6 units on a scale Standard Deviation 27.7
Quality of Life - SF-36 - Social Aspects After 16 weeks	47.6 units on a scale Standard Deviation 24.5	64.1 units on a scale Standard Deviation 28
Quality of Life - SF-36 - Social Aspects After 32 weeks	51.3 units on a scale Standard Deviation 25.5	57.2 units on a scale Standard Deviation 27

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 from 100, with higher scores denoting better quality of life

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Quality of Life - SF-36 - Emotional Aspects Baseline	21.2 units on a scale Standard Deviation 33.1	34.2 units on a scale Standard Deviation 36.9
Quality of Life - SF-36 - Emotional Aspects After 16 weeks	17.5 units on a scale Standard Deviation 26.1	55 units on a scale Standard Deviation 33.6
Quality of Life - SF-36 - Emotional Aspects After 32 weeks	31.5 units on a scale Standard Deviation 38.7	51.9 units on a scale Standard Deviation 39.6

SECONDARY outcome

Timeframe: baseline, after 16 weeks and after 32 weeks

score between 0 from 100, with higher scores denoting better quality of life

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Quality of Life - SF-36 - Mental Health Baseline	43.4 units on a scale Standard Deviation 24	46 units on a scale Standard Deviation 19.9
Quality of Life - SF-36 - Mental Health After 16 weeks	44.5 units on a scale Standard Deviation 26.6	54.2 units on a scale Standard Deviation 20.7
Quality of Life - SF-36 - Mental Health After 32 weeks	46.2 units on a scale Standard Deviation 22.6	52.3 units on a scale Standard Deviation 20.8

SECONDARY outcome

Timeframe: Baseline, after 16 weeks and after 32 weeks

score between 0 from 63, with higher score indicating greater depression

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Depression - Beck Inventory Baseline	21.2 units on a scale Standard Deviation 13	23.9 units on a scale Standard Deviation 14.7
Depression - Beck Inventory After 16 weeks	23.5 units on a scale Standard Deviation 11.5	20.2 units on a scale Standard Deviation 13.2
Depression - Beck Inventory After 32 weeks	23.5 units on a scale Standard Deviation 13.7	23.1 units on a scale Standard Deviation 15.3

SECONDARY outcome

Timeframe: Baseline, after 16 weeks and after 32 weeks

scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image

Outcome measures

Measure	Control Group n=40 Participants The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).	Dance Group n=40 Participants The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
Self-image - Body Dysmorphic Disorder Examination Questionnaire After 16 weeks	50.5 units on a scale Standard Deviation 29.4	33.6 units on a scale Standard Deviation 25.9
Self-image - Body Dysmorphic Disorder Examination Questionnaire After 32 weeks	46.9 units on a scale Standard Deviation 31.8	41.1 units on a scale Standard Deviation 24.4
Self-image - Body Dysmorphic Disorder Examination Questionnaire Baseline	48.8 units on a scale Standard Deviation 34.2	42.8 units on a scale Standard Deviation 32.6

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andreia S Baptista, PT

Federal University of Sao Paulo

Phone: 551155764239

Email: deiasalvador1@yahoo.com.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place