Appendix 1Changes to protocol
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| Changes to protocol | Progress report | Date | Approved by |
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| Protocol Version 2 (11 June 2014) |
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| This protocol amendment was in relation to the following: the exclusion criterion ‘involvement in another randomised controlled trial’ was added and it was stated that their GP will be informed of the participant’s involvement via post. Both were added as a result of the original ethical review process | 1 (31 October 2014) | 4 July 2014 | NRES Committee East of England – Cambridge South |
| Protocol Version 3 (15 August 2014) |
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| This protocol amendment was in relation to the following: it was clarified that the 6MWD should be completed only once at baseline and 26 weeks. The NSAA score and FVC for visit 1 are both routine measurements and are completed each time a participant attended clinic; therefore, the protocol was updated to state a NSAA or FVC completed up to 4 weeks before consent could be used as the data for visit 1. The pain VAS and urine dipstick would now be completed before and after each AT session. The chief investigator was removed as being blind from treatment allocation. Inclusion criterion 3 was amended to clarify what classed as ‘no major changes to drug, dosage or frequency’. Renal failure was listed as a contraindication and precaution in error, and was therefore removed as a precaution. Transient conditions in Table 2 were amended to clarify that participants should be excluded until the condition resolved. The window for trial interventions to begin was extended to within 2–4 weeks of the date of randomisation. It was clarified that ‘receipt of intervention’ and ‘the number of sessions attended’ would be feasibility outcomes for the study and not protocol non-compliance. The trial interventions section relating to the control group was amended to clarify that the research physiotherapists would prescribe the LBT and inform the community physiotherapist about the combination of exercises prescribed; in addition, parents would post the completed LBT forms to the university team or hand them to the research physiotherapist. Participants were also asked to take their LBT prescription to the community physiotherapist so that the community physiotherapist can note any changes. The process of sending up to three reminder letters to parents was outlined. Data handling and record keeping were clarified, for example regarding the qualitative element of the trial in which researchers would contact the participants. The words ‘and SARs’ were removed from the description about SUSARs. Finally the sentence ‘The Medicines for Human Use (Clinical Trials) Regulations 2004 SI: 1031 plus subsequent amendments’ was replaced with ‘This clinical trial will be conducted in accordance with Good Clinical Practice Guidelines and CTRU standard operating procedures’ as the trial was not a CTIMP | 2 (1 May 2015) | 26 November 2014 | NRES Committee East of England – Cambridge South |
| Protocol Version 4 (9 January 2015) |
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| This protocol amendment was in relation to the following: one of the clinical outcomes that the trial intended to measure was whether or not myoglobin was present in the urine of participants who underwent AT. This outcome was removed because of the following reasons: clinically, it was felt that pain and exertion were the most important key outcomes before/after AT sessions, these were already being measured for the trial; research physiotherapists who routinely administer physiotherapy and AT advised that taking urine samples for dipstick testing is not a standard measure taken for children who undergo AT routinely; biochemistry colleagues advised that such testing was unlikely to detect myoglobinuria immediately after exercise such as AT; both the research ethics committee and NIHR expressed concerns about the burden of this testing for participants and their families | 2 (1 May 2015) | 30 January 2015 | NRES Committee East of England – Cambridge South |
| Protocol Version 5 (30 October 2015) |
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| The references were updated in section 6.4 of the protocol | Approved after final progress report submitted | n/a | NRES Committee East of England – Cambridge South |
| Protocol Version 6 (18 November 2015) |
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| This protocol amendment was in relation to the following: Version 5 of the protocol allowed the collection of a post-AT session OMNI score to measure the level of exertion in boys after their AT session. The physiotherapists delivering the intervention felt that it was clinically important to measure their pre-AT levels of exertion and, as such, an amendment was submitted to allow the analysis of these data. We gained approval to include the pre-AT OMNI data collected | Approved after final progress report submitted | n/a | NRES Committee East of England – Cambridge South |
CTIMP, clinical trial of an investigational medicinal product; GP, general practitioner; n/a, not applicable; NRES, National Research Ethics Service; SAR, serious adverse reaction; SUSAR, suspected unexpected serious adverse reaction; VAS, visual analogue scale.
