Methods |
Design: three group parallel trial
Purpose: examine the effect of exercise health counselling |
Participants |
Patients: elderly out‐patients with chronic illnesses
Baseline comparability: yes |
Interventions |
Placebo: sessions of disease management or prevention unrelated to physical activity and with no efforts made to modify behaviour ('attention control')
Untreated: no sessions
Experimental: sessions aiming at providing patient centred motivational, behavioural, and cognitive techniques to increase physical activity
(Co‐intervention: NS) |
Outcomes |
Physical activity (CHAMPS questionnaire)
‐weekly frequency
‐caloric expenditure
‐estimated total minutes (estimated moderate minutes + estimated walk/bike minutes) |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
'computer‐generated' |
Allocation concealment? |
Unclear risk |
NS |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (attention control placebo/exercise health counselling) |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Low risk |
|
No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
Trial size > 49? |
Low risk |
N = 80 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |