Sanudo 2010.
Methods | 3 groups: aerobic exercise (AE); mixed exercise (aerobic + resistance + flexibility); control Length: 24 weeks; follow‐up: none Study design: randomized clinical trial with parallel groups |
|
Participants | Female:Male: 64:0 Age (years (SE)): 55.9 (1.6); 55.9 (1.7); 56.6 (1.9) Inclusion: women with diagnosis of fibromyalgia (ACR 1990) Exclusion: presence of inflammatory rheumatic disease and severe psychiatric illness, respiratory or cardiovascular disease that prevented physical exertion, women with fibromyalgia receiving psychological or physical therapy to avoid possible interactions with the present trial Duration of illness (years (SD)): not specified for either group |
|
Interventions |
Aerobic exercise (n = 22): supervised aerobic exercise intervention. Frequency: 2/wk; Duration: 45‐60' (10' warm‐up and 5‐10' cool‐down, 15‐20' of steady state AE, 15' interval training); Intensity: light to moderate (steady state aerobic 60%‐65% of HRmax) and moderate to vigorous (interval training 75%‐80% HRmax); Mode: Warm‐up included slow walks, easy movements of progressive intensity, steady state AE included continuous walking with arm movements and jogging, interval training included aerobic dance and jogging, cool‐down included slow walks, easy movements, relaxation training Mixed exercise (aerobics, resistance, flexibility) (n = 21): combined supervised aerobic exercise and resistance exercise. Frequency: 2/wk; Duration: AE and RT same duration, which included 10' warm‐up, 10‐15' AE, 15‐20' RT, 10' FX;Intensity: AE 65%‐75% HRmax, RT weights 1‐3 kg; Mode: RT 1 set of 8‐10 reps for 8 different muscle groups with a load of 1‐3 kg, FX 1 set of 3 reps of 8‐9 different exercises, maintaining stretch position for 30 seconds, RT and FX exercises focused on main areas of pain in patients with fibromyalgia (deltoids, biceps, neck (trapezius), hops (gluteus, quadriceps), back/chest/torso (latissimus dorsi, pectoralis major, abdominals)) Control group (n = 21): received medical treatment for fibromyalgia and continued normal daily activities, which did not include structured exercise *For this review: only aerobic exercise and control group were considered |
|
Outcomes | Health‐related quality of life (FIQ Total), pain (SF‐36), fatigue (SF‐36), physical function (SF‐36), CR submax (6‐minute walk test) Other: muscle strength (grip strength), depression (Beck Depression Inventory) Measurements taken at 0 and 24 weeks |
|
Adherence to exercise protocols | Monitoring methods: HR monitoring but unreported results and attendance; adherence criteria: not stated; adherence: attendance rate in 89% and in 86% | |
Congruence with ACSM guidelines for aerobic training | No, based on frequency (only twice a week) for aerobics | |
Notes | Country: Spain Language: English Study author contacted: yes, study author confirmed that data from 2 studies (J Rehabil Med 2011), although similar, were from 2 different groups of people Funding sources: none stated |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer random number generator was used |
Allocation concealment (selection bias) | Low risk | Randomization by member not involved in recruitment or assessment of patients; randomization list kept at a separate location in a locked filing cabinet (page 1839) |
Blinding of self reported outcome assessment (detection bias) All outcomes | High risk | Self‐report instruments: health‐related quality of life (FIQ Total), pain (SF‐36), fatigue (SF‐36), physical function (SF‐36) |
Blinding of objective outcome assessment (detection bias) All outcomes | Unclear risk | CR submax (6‐minute walk test). No information provided on blinding |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Insufficient information on blinding of participants and personnel to permit judgment of risk |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were analyzed by intention‐to‐treat |
Selective reporting (reporting bias) | Low risk | Study protocol is available and all of the study's prespecified outcomes of interest in the review have been reported in the prespecified way |
Other bias | Low risk | Study appears to be free of other sources of bias |