Inspiratory muscle training in people with chronic obstructive pulmonary disease (COPD): a systematic review

Mota, Jennyfer Correa; Santos, Marcilene Rodrigues dos; Sousa, Luane Rodrigues de; Abdoral, Patrick Roberto Gomes; Abdoral, Larissa Siqueira Rodrigues; Miranda, Cláudia Jeane Claudino de Pontes

doi:10.1590/1809-2950/e21028823en

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ORIGINAL RESEARCH • Fisioter. Pesqui. 30 • 2023 • https://doi.org/10.1590/1809-2950/e21028823en copy

Inspiratory muscle training in people with chronic obstructive pulmonary disease (COPD): a systematic review

Entrenamiento de los músculos inspiratorios en personas con enfermedad pulmonar obstructiva crónica (EPOC): una revisión sistemática

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

This systematic review aimed to demonstrate the effectiveness of inspiratory muscle training (IMT) in people with chronic obstructive pulmonary disease (COPD), analyzing the effects of IMT on inspiratory muscle strength and endurance, exercise tolerance and reduction of dyspnea. A systematic search was carried out in the PubMed, Cochrane and Lilacs databases, from August 2021 to February 2023, searching for studies published from 2016. The descriptors used for the search followed the description of the MeSH/DeCS terms, namely: “Pulmonary Disease, Chronic Obstructive,” “Breathing Exercises,” “Exercise Tolerance,” “Dyspnea,” and “Muscle strength,” with the languages: English and Portuguese, using the Boolean operators “AND” and “OR.” Ten studies met the inclusion criteria, including 733 patients. In all examined studies, there was a significant increase in inspiratory muscle strength and endurance compared to the control group; of the ten studies analyzed, four showed advances in reducing dyspnea and exercise tolerance. Notably, inspiratory muscle training is effective in improving dyspnea, exercise tolerance, and in increasing inspiratory muscle strength and endurance in people with moderate to severe COPD.

Keywords:
Pulmonary Disease; Chronic Obstructive; Breathing Exercises; Exercise Tolerance; Dyspnea; Muscle Strength

Authorship (year)	Type of study	Sample	Groups	Intervention	Results
Authorship (year)	Type of study	Sample	Groups	Intervention	Increased inspiratory muscle strength and endurance	Improved exercise tolerance	Decreased dyspnea
Cutrim et al.⁹9. Cutrim ALC, Duarte AAM, Silva-Filho AC, Dias CJ, Urtado CB, et al. Inspiratory muscle training improves autonomic modulation and exercise tolerance in chronic obstructive pulmonary disease subjects: a randomized-controlled trial. Respir Physiol Neurobiol. 2019;263:31-7.doi: 10.1016/j.resp.2019.03.003. https://doi.org/10.1016/j.resp.2019.03.0... (2019)	Randomized clinical trial	Male: 17	IMTG (11)	Training time: 30min*/day	IMTG showed improvement in MIP after 12 weeks when compared with the control group.	IMTG showed no significant improvement in exercise tolerance when compared with CG in the 6MWT.	IMTG did not show significant improvements in the reduction of dyspnea when compared with CG in the 6MWT.
		Female: 5	CG (11)	Training frequency: 3×/week	The MIP of the study participants before the intervention was ±62cmH₂O*; after the intervention, the MIP was ±84cmH₂O.
		Age: ±66 to 80 years		Total intervention time: 12 weeks
				Device used: Threshold Inspiratory Muscle Training; POWERbreathe Medic +Plus
				Load adopted: 30% of the initial MIP*.
				CG: control group who received no intervention and was evaluated before and after 12 weeks.
Chuang et al. ⁽¹⁰10. Chuang HY, Chang HY, Fang YY, Guo SE. The effects of threshold inspiratory muscle training in patients with chronic obstructive pulmonary disease: a randomized experimental study. J Clin Nurs. 2017;26(23-24):4830-8. doi: 10.1111/jocn.13841. https://doi.org/10.1111/jocn.13841... (2017)	Randomized Clinical Study	Male: 36	IMTG (27)	Training time: 21 to 30min/day, consisting of a IMT cycle of 2min and 1min of rest; and then seven repeated cycles.	IMTG showed significant improvement in MIP when compared with CG.	IMTG showed an increase in distance in the 6MWT of 47.8±1.46 meters, while CG showed an increase of 5.6±1.1 meters.	IMTG showed an increase in BDI, from 4.48±2.12 points to 9.0±2.27 points. Consequently, there was a reduction in dyspnea.
		Female: 19	CG (28)	Training frequency: 5×/week	The mean improvement in MIP in the IMT group was (−17.6±0.18cmH₂O), while in the CG it was (−2.21±0.4cmH₂O)
		Age: ≥66		Total intervention time: eight weeks.
				Device used: NS
				Load adopted: NS
				CG: only medical treatment and routine care were provided, without intervention.
Langer et al. ⁽¹¹11. Langer D, Ciavaglia C, Faisal A, Webb KA, Neder JA, et al. Inspiratory muscle training reduces diaphragm activation and dyspnea during exercise in COPD. J Appl Physiol (1985). 2018;125(2):381-92. doi: 10.1152/japplphysiol.01078.2017. https://doi.org/10.1152/japplphysiol.010... (2018)	Study Clinical Randomized	Male: 7	IMTG (10)	Training time: 15min/session Training frequency: 2 to 3×/day, 4 to 7×/week.	IMTG showed significant improvement in MIP after the intervention: the initial value (−76±16cmH₂O) increased to −80±15cmH₂O after IMT.	IMTG showed reduced dyspnea during cycling exercise. It was observed that the exercise time increased more in the IMT group when compared with the CG.	IMTG showed a significant decrease in the dyspnea scale, whose initial value was 3.0±1.0; and after the intervention, 2.9±1.0. Unlike the CG, which maintained the same pattern (3.0±1.1).
		Female: 13	CG (10)	Total intervention time: eight weeks.
		Age: ≥70		Device used: electronic device POWERbreathe KH2.
				Adopted load: initial load was ±40% of the base MIP and was progressively increased up to 40% to 50% of the current MIP.
				CG: performed three daily sessions with unchanged load of ≤10% of the initial MIP.
Charususin et al. ⁽¹²12. Charususin N, Gosselink R, Decramer M, Demeyer H, McConnell A, et al. Randomised controlled trial of adjunctive inspiratory muscle training for patients with COPD. Thorax. 2018;73(10):942-50. doi: 10.1136/thoraxjnl-2017-211417. https://doi.org/10.1136/thoraxjnl-2017-2... (2018)	Randomized clinical trial	Male: 95	IMTG (85)	Training time: 60min/session.	IMTG showed greater improvements in inspiratory muscle strength when compared with CG. The baseline MIP training load in the first week was 47±2% and evolved to 84±4% of their baseline MIP at week 12^.	IMTG showed an additional 75s improvement in endurance time in cycling exercise. However, no significant differences were observed between IMTG and CG in the 6MWT.	IMTG showed significant reductions in the Borg dyspnea score during the cycling test, after IMT.
		Female: 124	CG (89)	Training frequency: 3 to 5 sessions/week.
		Age: ≥65		Total intervention time: from 20 to 36 sessions.
				Device used: POWERbreathe KHP2.
				Load adopted: NS
				CG: Both groups undertook an identical general training program. However, the intensity of training in the intervention group was initially defined as a load of approximately 50% of the maximum inspiratory pressure of the patient’s mouth (MIP). The training intensity in the control group was set at 10% of baseline MIP and was not modified throughout the intervention period.
Mehani¹³13. Mehani SHM. Comparative study of two different respiratory training protocols in elderly patients with chronic obstructive pulmonary disease. Clin Interv Aging. 2017;12:1705-15. doi: 10.2147/CIA.S145688. https://doi.org/10.2147/CIA.S145688... (2017)	Randomized clinical trial	Male: 40.	IMTG (20)	Training time: six sessions of five deep breaths each.	IMTG showed a significant increase in MIP, and the initial value of −0.59±0.83cmH₂O increased to −23.18±4.63cmH₂O after the intervention.	IMTG expressed a significant increase in the 6MWT, about 25% when compared with the CG, which had an increase of 2.5%.	This variable was not evaluated in the study.
		Age: ≥59	CG (20)	Training frequency: 3×/week
				Total intervention time: two months.
				Device used: Threshold/Respironics Inc.
				Load adopted: 15% of baseline MIP, increasing by 5% to 10% to reach 60% of baseline MIP. They also received placebo EMT with a fixed load of 7cmH₂O.
				CG: Received EMT with an initial load of 15% of their baseline MEP and progressively increased to 60%. They also received placebo IMT with a fixed load of 7cmH₂O.
Beaumont et al. ⁽¹⁴14. Beaumont M, Mialon P, Le Ber C, Le Mevel P, Péran L, et al. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomized trial. Eur Respir J. 2018;51(1):1701107. doi: 10.1183/13993003.01107-2017. https://doi.org/10.1183/13993003.01107-2... (2018)	Randomized clinical trial	Male: 94	GTMI+PR (74)	Training time: 15min/session	IMTG showed a significant increase in MIP (−14.8cmH₂O) when compared with CG, which showed an increase of −9.9cmH₂O.	IMTG reported no significant difference in the 6MWT.	IMTG showed a reduction in dyspnea, assessed using the Borg scale and the mMRC scale. (Borg 5.4±2.2 to 4.0±2.1; mMRC 2.3±1.1 to 1.4±1.2)
		Female: 55	CG (75)	Training frequency: 2 sessions/day, 5×/week.
		Age: 60 to 65 years		Total intervention time: four weeks
				Device used: PowerBreathe Medic.
				Load adopted: 50% of the initial MIP of each session, the load was increased (±10%) after 10 days of training during the program, to reach 60% of the initial MIP. They also received a standardized pulmonary rehabilitation program.
				CG: received a standardized PR program for a period of four weeks.
Wu et al. ⁽¹⁵15. Wu W, Guan L, Zhang X, Li X, Yang Y, et al. Effects of two types of equal-intensity inspiratory muscle training in stable patients with chronic obstructive pulmonary disease: a randomised controlled trial. Respir Med. 2017;132:84-91. doi: 10.1016/j.rmed.2017.10.001. https://doi.org/10.1016/j.rmed.2017.10.0... ^)_ (2017)	Randomized clinical trial	60 patients	IMTG 1 (21)	Training time: 30min/day, divided into two cycles of 15min.	GTMI 1 showed a significant increase in inspiratory muscle strength after IMT. MIP increased from −37.31±6.18cmH₂O to −45.77±5.84cmH₂O after IMT.	The intervention groups significantly increased in the duration of cycling exercise. The IMTG 1 went from 401.84±97.29s to 405.58±96.57s. While IMTG 2 went from 429.10±105.50s to 522.05±129.41s, indicating increased exercise tolerance.	The IMT groups, in the BDI*, showed improvement after the IMT.
		Sex: NS	IMTG 2 (19)	Training frequency: 7×/week	IMTG 2 also showed improvement in inspiratory muscle strength: MIP increased from −37.53±6.46cmH₂O to −45.11±8.71cmH₂O after IMT.		IMTG 2: 2.52±2.04; IMTG 1: 1.58±2.93, significant improvement compared with CG (0.30±3.31).
		Age: 59 to 62 years	CG (20)	Total intervention time: eight weeks.	There was no significant difference between IMT groups 1 and 2.		There was no significant difference in BDI between the three groups.
				Device used: IMTG 1 used the Inspiratory Resistive Training PFLEX device; IMTG 2 used the Threshold Inspiratory Muscle Training device.
				Load adopted: 60% of MIP.
				CG: did not receive any intervention other than medication, did not include any rehabilitation program for eight weeks.
Arnedillo et al. ⁽¹⁶16. Arnedillo A, Gonzalez-Montesinos JL, Fernandez-Santos JR, Vaz-Pardal C, España-Dominguez C, et al. Effects of a rehabilitation programme with a nasal inspiratory restriction device on exercise capacity and quality of life in COPD. Int J Environ Res Public Health. 2020;17(10):3669. doi: 10.3390/ijerph17103669. https://doi.org/10.3390/ijerph17103669... (2020)	Randomized clinical trial	16 patients	IMTG (7)	Training time: 60min/session.	IMTG achieved a significant increase in MIP when compared with CG 1 and CG 2.	IMTG obtained a greater increase in the distance covered in the 6MWT in relation to CG 1 and CG 2.	This variable was not evaluated in the study.
		Sex: NS	CG 1 (5)	Training frequency: 3×/week
		Age: ≥65	CG 2 (4)	Total intervention time: eight weeks.
				Device used: nasal restriction device for inspiratory muscle training called Feelbreathe, associated with a PR program composed of warm-up phase, main phase, and recovery phase.
				Load adopted: NS.
				CGs: CG 1 received the same pulmonary rehabilitation as the intervention group, but without IMT (Feelbreathe). CG 2 received standard medical recommendations for patients with COPD.
Xu et al. ⁽¹⁷17. Xu W, Li R, Guan L, Wang K, Hu Y, et al. Combination of inspiratory and expiratory muscle training in same respiratory cycle versus different cycles in COPD patients: a randomized trial. Respir Res. 2018;19(1):225. doi: 10.1186/s12931-018-0917-6. https://doi.org/10.1186/s12931-018-0917-... (2018)	Randomized clinical trial	Male: 82	IMTG (21)	Training time: 48min/session, 3min of training and 2min of rest.	The MIP of IMTG, CG A, and CG B was significantly higher than CG C (only group that did not perform IMT).	IMTG, CG A, and CG B showed a decrease in the degree of dyspnea, indicating that respiratory muscle training can relieve dyspnea in patients with COPD.	IMTG did not show significant improvements in the reduction of dyspnea, when compared with the control groups in the 6MWT.
		Female: 5	CG A (22)	Training frequency: 7×/week
			CG B (22)	Total intervention time: eight weeks.
			CG C (22)	Device used: Threshold IMT and Threshold PEP.
				Load adopted: NS. The IMT group performed eight series of IMT and eight series of respiratory muscle training without any daily load.
				CGs: CG A performed 16 training sets daily, combined with a respiratory cycle. CG B performed eight series of IMT and eight series of EMT separately in different daily cycles. CG C performed 16 sets of respiratory muscle training without any daily load.
Buran Cirak et al. ⁽¹⁸18. Buran Cirak Y, Yilmaz Yelvar GD, Durustkan Elbasi N. Effectiveness of 12-week inspiratory muscle training with manual therapy in patients with COPD: a randomized controlled study. Clin Respir J. 2022;16(4):317-28. doi: 10.1111/crj.13486. https://doi.org/10.1111/crj.13486... (2022)	Prospective, randomized, double-blinded, placebo-controlled study	Male: 49	IMTG (30)	Training time: 15min/day.	IMTG showed improvement in MIP after 12 weeks when compared with CG.	The studied group (395.1-467.2) did not present significant improvements in exercise tolerance when compared with the CG (386.7-430.2) in the 6MWT.	The benefit of IMT in dyspnea was evaluated using the dyspnea scale, showing a decrease in dyspnea in both groups, but a more noticeable decrease in symptoms in IMTG.
		Female: 11	CG (30)	Training frequency: every day.	The MIP of the study participants before the intervention was ±62cmH₂O*; after the intervention, the MIP was ±84cmH₂O.
		Age: ≥62		Total time of the intervention: 12 weeks
				Device used: Threshold IMT.
				Load adopted: 40% of the initial MIP.
				CG: control group who received no intervention and was evaluated before and after 12 weeks.

COCHRANE SCALE	Randomization sequence generation	Allocation secrecy	Blinding of participants and staff	Blinding of outcome assessment	Incomplete outcome data	Selective reporting of outcomes	Other sources of bias
Cutrim et al.⁹9. Cutrim ALC, Duarte AAM, Silva-Filho AC, Dias CJ, Urtado CB, et al. Inspiratory muscle training improves autonomic modulation and exercise tolerance in chronic obstructive pulmonary disease subjects: a randomized-controlled trial. Respir Physiol Neurobiol. 2019;263:31-7.doi: 10.1016/j.resp.2019.03.003. https://doi.org/10.1016/j.resp.2019.03.0... ⁾ (2019)	Low risk	Low risk	Low risk	Low risk	Low risk	Low risk	Uncertain risk
Chuang et al. ⁽¹⁰10. Chuang HY, Chang HY, Fang YY, Guo SE. The effects of threshold inspiratory muscle training in patients with chronic obstructive pulmonary disease: a randomized experimental study. J Clin Nurs. 2017;26(23-24):4830-8. doi: 10.1111/jocn.13841. https://doi.org/10.1111/jocn.13841... (2017)	Low risk	Low risk	Low risk	Uncertain risk	Low risk	Low risk	Uncertain risk
Langer et al. ⁽¹¹11. Langer D, Ciavaglia C, Faisal A, Webb KA, Neder JA, et al. Inspiratory muscle training reduces diaphragm activation and dyspnea during exercise in COPD. J Appl Physiol (1985). 2018;125(2):381-92. doi: 10.1152/japplphysiol.01078.2017. https://doi.org/10.1152/japplphysiol.010... (2018)	Low risk	Low risk	Low risk	Low risk	Low risk	Low risk	Uncertain risk
Charususin et al. ⁽¹²12. Charususin N, Gosselink R, Decramer M, Demeyer H, McConnell A, et al. Randomised controlled trial of adjunctive inspiratory muscle training for patients with COPD. Thorax. 2018;73(10):942-50. doi: 10.1136/thoraxjnl-2017-211417. https://doi.org/10.1136/thoraxjnl-2017-2... (2018)	Low risk	Low risk	Low risk	Uncertain risk	Low risk	Low risk	Uncertain risk
Mehani¹³13. Mehani SHM. Comparative study of two different respiratory training protocols in elderly patients with chronic obstructive pulmonary disease. Clin Interv Aging. 2017;12:1705-15. doi: 10.2147/CIA.S145688. https://doi.org/10.2147/CIA.S145688... ⁾ (2017)	Low risk	Low risk	Uncertain risk	Low risk	Low risk	Low risk	Uncertain risk
Beaumont et al. ⁽¹⁴14. Beaumont M, Mialon P, Le Ber C, Le Mevel P, Péran L, et al. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomized trial. Eur Respir J. 2018;51(1):1701107. doi: 10.1183/13993003.01107-2017. https://doi.org/10.1183/13993003.01107-2... ⁾ (2018)	Low risk	Low risk	Low risk	Low risk	Low risk	Low risk	Uncertain risk
Wu et al. ⁽¹⁵15. Wu W, Guan L, Zhang X, Li X, Yang Y, et al. Effects of two types of equal-intensity inspiratory muscle training in stable patients with chronic obstructive pulmonary disease: a randomised controlled trial. Respir Med. 2017;132:84-91. doi: 10.1016/j.rmed.2017.10.001. https://doi.org/10.1016/j.rmed.2017.10.0... ⁾ (2017)	Low risk	Low risk	Low risk	Low risk	Low risk	Low risk	Uncertain risk
Arnedillo et al. ⁽¹⁶16. Arnedillo A, Gonzalez-Montesinos JL, Fernandez-Santos JR, Vaz-Pardal C, España-Dominguez C, et al. Effects of a rehabilitation programme with a nasal inspiratory restriction device on exercise capacity and quality of life in COPD. Int J Environ Res Public Health. 2020;17(10):3669. doi: 10.3390/ijerph17103669. https://doi.org/10.3390/ijerph17103669... (2020)	Low risk	Low risk	Low risk	Low risk	Low risk	Low risk	Uncertain risk
Xu et al. ⁽¹⁷17. Xu W, Li R, Guan L, Wang K, Hu Y, et al. Combination of inspiratory and expiratory muscle training in same respiratory cycle versus different cycles in COPD patients: a randomized trial. Respir Res. 2018;19(1):225. doi: 10.1186/s12931-018-0917-6. https://doi.org/10.1186/s12931-018-0917-... (2018)	Low risk	Low risk	Low risk	Low risk	Low risk	Low risk	Uncertain risk
Buran Cirak et al. ⁽¹⁸18. Buran Cirak Y, Yilmaz Yelvar GD, Durustkan Elbasi N. Effectiveness of 12-week inspiratory muscle training with manual therapy in patients with COPD: a randomized controlled study. Clin Respir J. 2022;16(4):317-28. doi: 10.1111/crj.13486. https://doi.org/10.1111/crj.13486... (2022)	Low risk	Low risk	Low risk	Low risk	Low risk	Low risk	Uncertain risk

Criteria	Cutrim et al. ⁽⁹9. Cutrim ALC, Duarte AAM, Silva-Filho AC, Dias CJ, Urtado CB, et al. Inspiratory muscle training improves autonomic modulation and exercise tolerance in chronic obstructive pulmonary disease subjects: a randomized-controlled trial. Respir Physiol Neurobiol. 2019;263:31-7.doi: 10.1016/j.resp.2019.03.003. https://doi.org/10.1016/j.resp.2019.03.0... ⁾ (2019)	Chuang et al. ⁽¹⁰10. Chuang HY, Chang HY, Fang YY, Guo SE. The effects of threshold inspiratory muscle training in patients with chronic obstructive pulmonary disease: a randomized experimental study. J Clin Nurs. 2017;26(23-24):4830-8. doi: 10.1111/jocn.13841. https://doi.org/10.1111/jocn.13841... (2017)	Langer et al. ⁽¹¹11. Langer D, Ciavaglia C, Faisal A, Webb KA, Neder JA, et al. Inspiratory muscle training reduces diaphragm activation and dyspnea during exercise in COPD. J Appl Physiol (1985). 2018;125(2):381-92. doi: 10.1152/japplphysiol.01078.2017. https://doi.org/10.1152/japplphysiol.010... (2018)	Charususin et al. ⁽¹²12. Charususin N, Gosselink R, Decramer M, Demeyer H, McConnell A, et al. Randomised controlled trial of adjunctive inspiratory muscle training for patients with COPD. Thorax. 2018;73(10):942-50. doi: 10.1136/thoraxjnl-2017-211417. https://doi.org/10.1136/thoraxjnl-2017-2... (2018)	Mehani¹³ (2017)	Beaumont et al. ⁽¹⁴14. Beaumont M, Mialon P, Le Ber C, Le Mevel P, Péran L, et al. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomized trial. Eur Respir J. 2018;51(1):1701107. doi: 10.1183/13993003.01107-2017. https://doi.org/10.1183/13993003.01107-2... (2018)	Wu et al¹⁵15. Wu W, Guan L, Zhang X, Li X, Yang Y, et al. Effects of two types of equal-intensity inspiratory muscle training in stable patients with chronic obstructive pulmonary disease: a randomised controlled trial. Respir Med. 2017;132:84-91. doi: 10.1016/j.rmed.2017.10.001. https://doi.org/10.1016/j.rmed.2017.10.0... (2017)	Arnedillo et al. ⁽¹⁶16. Arnedillo A, Gonzalez-Montesinos JL, Fernandez-Santos JR, Vaz-Pardal C, España-Dominguez C, et al. Effects of a rehabilitation programme with a nasal inspiratory restriction device on exercise capacity and quality of life in COPD. Int J Environ Res Public Health. 2020;17(10):3669. doi: 10.3390/ijerph17103669. https://doi.org/10.3390/ijerph17103669... (2020)	Xu et al. ⁽¹⁷17. Xu W, Li R, Guan L, Wang K, Hu Y, et al. Combination of inspiratory and expiratory muscle training in same respiratory cycle versus different cycles in COPD patients: a randomized trial. Respir Res. 2018;19(1):225. doi: 10.1186/s12931-018-0917-6. https://doi.org/10.1186/s12931-018-0917-... (2018)	Buran Cirak et al. ⁽¹⁸18. Buran Cirak Y, Yilmaz Yelvar GD, Durustkan Elbasi N. Effectiveness of 12-week inspiratory muscle training with manual therapy in patients with COPD: a randomized controlled study. Clin Respir J. 2022;16(4):317-28. doi: 10.1111/crj.13486. https://doi.org/10.1111/crj.13486... (2022)
Eligibility criteria have been specified	1	1	1	1	1	1	1	1	1	1
The subjects were randomly distributed into groups (in a crossover study, the subjects were randomly placed in groups according to the treatment received)	1	1	1	1	1	1	1	1	1	1
The allocation of subjects was secret	1	1	1	1	1	1	0	0	1	1
Initially, the groups were similar concerning the most important prognostic indicators	1	0	1	1	1	0	1	1	1	1
All subjects were blinded in the study	0	1	1	1	1	1	0	0	0	0
All the therapists who administered the therapy did so blindly	0	0	0	1	1	1	0	0	0	0
All evaluators who measured at least one key outcome did so blindly	1	0	1	1	1	1	0	0	0	0
Measurements of at least one key outcome were obtained in more than 85% of the subjects initially distributed in the groups	1	1	1	1	0	1	1	0	1	1
All subjects from whom outcome measurements were presented received the treatment or control condition according to allocation or, when this was not the case, data analysis of at least one of the key outcomes was performed by “intention to treat”	1	1	1	1	1	1	1	1	1	1
The results of the intergroup statistical comparisons have been described for at least one key result	1	1	1	1	1	1	1	1	1	1
The study presents both precision measures and measures of variability for at least one key outcome	1	1	1	1	1	1	1	1	1	1
Total score for PEDro scale	9	8	10	11	10	10	7	6	8	8

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[1] Corresponding address: Patrick Roberto Gomes Abdoral - Rua Jabatiteua, 894 - Belém (PA), Brazil - ZIP Code: 66070-260 - E-mail: patrickabdoral@gmail.com