Skip to main content
. 2017 Dec 21;2017(12):CD009424. doi: 10.1002/14651858.CD009424.pub2

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
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.
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.