Exercise Therapy, Pain
Conditions
Keywords
Fibromyalgia, Physical activity, Function, Pain, Exercise, Inflammation
Brief summary
The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.
Interventions
BEHAVIORALPhysical exercise
Supervised walks with poles twice a week at moderate-high intensity
BEHAVIORALActive comparator: low intensive exercise
Supervised walks once a week at low-intensity.
Sponsors
Sahlgrenska University Hospital
Västra Götalands Forskningsfond
Reumatikerförbundet
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Women with Fibromyalgia, interested in exercise twice a week
Exclusion criteria
* Other severe diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute Walk Test | 15 weeks | Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented. |
| Change of Pain Level From Baseline. | 15 weeks | Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A. High Intensive Exercise High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks | 34 |
| B. Low-intensive Exercise Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks | 33 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
Baseline characteristics
| Characteristic | B. Low-intensive Exercise | A. High Intensive Exercise | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 34 Participants | 67 Participants |
| Age Continuous | 50 years STANDARD_DEVIATION 7.6 | 48 years STANDARD_DEVIATION 7.8 | 49 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment Sweden | 33 participants | 34 participants | 67 participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Change of Pain Level From Baseline.
Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain.
Time frame: 15 weeks
Population: Patients attending at post-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Exercise | Change of Pain Level From Baseline. | -4.0 mm | Standard Deviation 14.5 |
| Arm B. Active Comparator | Change of Pain Level From Baseline. | -5.3 mm | Standard Deviation 16.3 |
Primary
Six-minute Walk Test
Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.
Time frame: 15 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Exercise | Six-minute Walk Test | 37.7 meter | Standard Deviation 41.8 |
| Arm B. Active Comparator | Six-minute Walk Test | 8.6 meter | Standard Deviation 42.2 |