Table 1 Additional file World Health Organisation trial registration data set for S.M.A.R.T.
Data category | Information |
|---|---|
Primary registry and trial identifying number | Australian New Zealand Clinical Trials Registry number: ACTRN12615000968572 |
Date of registration in primary registry | 16 September 2015 |
Secondary identifying numbers | N/A |
Trial protocol version | This is the version 3 of the protocol and was enacted November 2015 |
Source(s) of monetary or material support | Nil |
Primary sponsor | Nil |
Secondary sponsor | Nil |
Contact for public queries | Professor Alistair Royse |
Contact for scientific queries | Dr Catherine Granger |
Public title | Sternal Management Accelerated Recovery Trial (S.M.A.R.T.): The efficacy of modified sternal precautions on improving physical function in patients following cardiac surgery via a midline sternal incision. |
Scientific title | A randomised controlled trial of the efficacy of modified sternal precautions versus standard care on improving physical function following cardiac surgery via a median sternotomy |
Countries of recruitment | Australia |
Health condition(s) or problem(s) studied | Cardiac surgery via a median sternotomy |
Intervention(s) | Active comparator: Placebo comparator: |
Key inclusion and exclusion criteria | Ages eligible for study: ≥18 years Sexes eligible for study: both Accepts health volunteers: No Inclusion criteria: all adults underwent elective cardia surgery involving a median sternotomy Exclusion criteria: 1. Unable to understand verbal instructions in English. 2. Residing outside Melbourne metropolitan area (i.e., 52-km radius). |
Study type | Type: Investigator initiated, interventional, non-pharmacological, pragmatic, study Allocation: concealed randomisation Intervention model: parallel assignment Masking: patient and assessor blinded Primary purpose: prevention |
Date of first enrolment | 16 September 2015 |
Target sample size | 72 |
Recruitment status | Completed recruitment on 16 November 2016 |
Primary outcome(s) | Short Physical Performance Battery (SPPB) |
Key secondary outcomes | 2. Patient-identified cardiac pain using numeric and visual prompts, Short Form McGill Pain Questionnaire 2 (SF-MPQ-2), Functional Difficulties Questionnaire (FDQ), grip strength, Tampa Scale of Kinesiophobia shortened version (TSK-11), Medical Outcomes Study 36-item Short Form Health Survey (SF-36v2), Global Rating of Change Scales |