Fry 2007.
Methods | Randomized controlled trial | |
Participants | N = 46 (23/23) randomized, N = 41 (20/21) analyzed Inclusion criteria: aged > 18 years, ambulatory, clinically diagnosed MS Exclusion criteria: acute respiratory infection, oral temperature > 100ºF, unstable physical conditions not related to MS, current smoking history Experimental group (N = 20): EDSS, mean ± SD: 3.96 ± 1.80 Age, mean ± SD: 50 ± 9.1 years Women: 91% MS type (%): RR 52; SP 16; PP 21; PR 11 Time since diagnosis: — Control group (N = 21): EDSS, mean ± SD: 3.36 ± 1.47 Age, mean ± SD: 46.2 ± 9.4 years Women: 74% MS type (%): RR 72; SP 18; PP 5; PR 5 Time since diagnosis: — Country: USA |
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Interventions |
Experimental group: Home‐based inspiratory muscle training with a threshold inspiratory muscle trainer device Duration: 3 months Frequency: 2 sessions daily Repetitions and sets: 3 sets of 15 repetitions Resistance and progression: initial resistance (H2O) IMT set on 30% of pretest PImax; weekly progression based on baseline MIP, Borg 6‐20 RPE, and symptoms Control group: No treatment, called at 4, 8 and 10 weeks to control for complications and for changes in level of physical activity. |
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Outcomes | PImax, predicted PImax (%), PEmax, predicted PEmax (%), MVV, predicted MVV (%), FSS, FVC, predicted FVC (%), FEV1, predicted FEV1 (%), FEV1/FVC, predicted FEV1/FVC (%), FEF 25‐75%, predicted FEF 25‐75%, VC, predicted VC (%), impaired ventilatory muscle strength inspiratory, impaired ventilatory muscle strength expiratory, pulmonary disorder classification, FSS | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote p 163: "participants were randomly placed into a home exercise I group or C group by date of enrolment in the study." |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No information Comment: blinding participants and personnel not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote p 163: "The investigator who conducted the pre‐pulmonary and post‐pulmonary function tests was blinded to group assignment." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote p 163: "Of the 46 subjects who participated in the pre‐test session, two withdrew due to illness unrelated to a neurological exacerbation and three subjects no longer wished to participate in the study." Comment: unclear which participants withdrew from which group and why. |
Selective reporting (reporting bias) | Unclear risk | No published study protocol available Comment: relevant outcomes, but not all (e.g., QoL, basic ADLs, cough efficacy), were reported. |