Physical fitness training for stroke patients (Review) - Update Software

Compliance with the scheduled exercise programme during training
sessions was described in only six trials. For cardiorespiratory
training interventions, Langhammer 2007 stated that the compliance
with the individualised training levels was ’high’, Pohl 2002
reported ’excellent tolerance’ of treadmill training, and Salbach
2004 maintained that most of the participants completed nine
out of 10 circuit training exercises. For mixed training, Duncan
1998 reported ’good compliance’ with home-based training and
Yang 2006 stated that mixed circuit training was ’performed as
planned’. Mead 2007 reported 94% to 99% compliance with circuit
training exercises ’tailored’ to individual requirements. Information
on compliance was not available for the remaining trials.
Risk of bias in included studies
Randomisation
One trial adopted a cross-over design with random allocation to the
order of the treatment sequences (Moore 2010). For the purpose of
this review we only analysed the results at the end of the first period,
as deriving from parallel groups. All remaining trials adopted a
parallel group design.
Methods of sequence generation were clearly reported in 16 out
of the 32 included trials. These included methods such as drawing
lots (Bale 2008), throwing dice (Langhammer 2007; Smith
2008), picking envelopes (Eich 2004; Pohl 2002; Yang 2006),
random number tables (da Cunha 2002), or computer-generated
lists (Bateman 2001; Cooke 2010; Donaldson 2009; James 2002;
Lennon 2008; Mead 2007; Mudge 2009; Salbach 2004; Sims
2009). To balance the numbers of participants to be assigned to
each intervention group block randomisation was used in 14 trials
(Bateman 2001; Cooke 2010; Donaldson 2009; Duncan 1998;
Duncan 2003; James 2002; Katz-Leurer 2003; Lennon 2008; Pohl
2002; Richards 1993; Richards 2004; Salbach 2004; Sims 2009;
Teixeira 1999). To balance participant characteristics between intervention
groups stratified randomisation was used in 11 trials.
Allocation to intervention groups was stratified according to different
participants’ characteristics: by gait performance (Moore
2010; Pohl 2002; Salbach 2004); by gender (Sims 2009); by age
and gender (Lennon 2008); by age, gender, and time since stroke
(Kim 2001); by age, gender, and disability (Mead 2007); by gender
and hemispheric lesion (Langhammer 2007); by functional
ability (Donaldson 2009; Richards 1993); and by stroke severity
(Winstein 2004). Six trials were described as randomised but did
not provide information on the methods used for generating random
assignments (Aidar 2007; Cuviello-Palmer 1988; Flansbjer
2008; Glasser 1986; Inaba 1973; Ouellette 2004; Potempa 1995).
Allocation concealment
Information on allocation concealment was available in less then
half of the included trials (13/32). One trial reported the use
of a central assignment (Mead 2007), another trial the use of
a third party (Duncan 1998), and two trials the use of sequentially
numbered sealed opaque envelopes (Cooke 2010; Donaldson
2009) as adequate mechanisms of allocation concealment. Most
trials reported the use of ’sealed envelopes’ but did not specify
whether they were sequentially numbered or opaque (Bateman
2001; Duncan 2003; Eich 2004; James 2002; Lennon 2008;
Moore 2010; Winstein 2004; Yang 2006), therefore we were unable
to exclude potential selection bias with certainty.
Intention-to-treat (ITT) analysis
Fourteen trials reported the use of an ITT approach for their analyses
(Bateman 2001; Donaldson 2009; Duncan 1998; Duncan
2003; Eich 2004; Flansbjer 2008; James 2002; Langhammer
2007; Mead 2007; Mudge 2009; Ouellette 2004; Potempa 1995;
Richards 2004; Sims 2009) although one of these trials (Bateman
2001) did not analyse data for the participants who dropped out
(where possible, we imputed these missing data).
Amongst the 18 trials that did not mention ITT, nine did not have
any missing data (Bale 2008; Cuviello-Palmer 1988; Glasser 1986;
Kim 2001; Moore 2010; Potempa 1995; Smith 2008; Teixeira
1999; Yang 2006).
Blinding
Participant blinding
Participants could not be blinded to physical training. In two trials,
however, participants were informed that they would receive one
of two different, potentially beneficial interventions (Kim 2001;
Mead 2007) without being given information on the types of interventions.
Similarly, in another trial (Donaldson 2009) participants
allocated to the experimental group were advised that they
were to be offered extra therapy but were not told which type of
therapy.
Investigator blinding
Physical fitness training for stroke patients (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
The outcome assessors were reported to be blinded in 19 of
the 32 included trials (Bale 2008; Bateman 2001; Cooke 2010;
Donaldson 2009; Duncan 2003; Eich 2004; Flansbjer 2008;
James 2002; Katz-Leurer 2003; Kim 2001; Langhammer 2007;
Mead 2007; Mudge 2009; Ouellette 2004; Pohl 2002; Richards
1993; Richards 2004; Salbach 2004; Yang 2006). Some of these
trials reported, however, that some degree of unmasking might
have occurred (Eich 2004; Mudge 2009; Salbach 2004). Participants
were instructed not to reveal group assignments in four trials
(Bateman 2001; Duncan 2003; Flansbjer 2008; Mead 2007).
Outcome assessment was not blinded in three trials (Moore 2010;
Smith 2008; Winstein 2004). Details of blinding were not provided
in the remaining trials.
10