Wisse 2010.
| Study characteristics | ||
| Methods |
Prescription of physical activity is not sufficient to change sedentary behavior and improve glycemic control in type 2 diabetes patients Patient RCT, conducted with patients recruited from an outpatient diabetes clinic (Slotervaart Hospital in Amsterdam), The Netherlands Two arms: 1. Control group (control arm) and 2. Intervention group (intervention arm) |
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| Participants | Control arm N: 36 Intervention arm N: 38 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 24 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Promotion of self‐management |
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| Outcomes | 1) Aspirin (aspirin/anticoagulants), N users (%) Control arm: pre 5 (17), post 9 (31) Intervention arm: pre 8 (25), post 14 (44) 2) Statins, N users (%) Control arm: pre 20 (69), post 24 (83) Intervention arm: pre 25 (78), post 28 (88) 3) Antihypertensives (any), N users (%) Control arm: pre 26 (90), post 22 (76) Intervention arm: pre 25 (78), post 21 (66) 4) HbA1c, mean % (SE) Control arm: pre 7.6 (0.2), post 7.9 (0.3) Intervention arm: pre 7.6 (0.2), post 7.6 (0.2) 5) SBP, mean mmHg (SE) Control arm: pre 137.0 (4.0), post 137.0 (3.0) Intervention arm: pre 130.0 (3.0), post 132.0 (3.0) 6) DBP, mean mmHg (SE) Control arm: pre 80.0 (2.0), post 82.0 (2.0) Intervention arm: pre 77.0 (1.0), post 76.0 (2.0) 7) LDL, mean mg/dL (SE) Control arm: pre 100.5 (3.9), post 92.8 (7.7) Intervention arm: pre 104.4 (3.9), post 96.7 (9.7) |
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| Funding source | Research grant: Novo Nordisk Farma B.V., Flemingweg 18, 2408 AV Alphen aan de Rijn, The Netherlands (www.novonordisk.nl) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Does not describe, just states that they were randomised. |
| Allocation concealment (selection bias) | Unclear risk | Does not describe, just states that they were randomised. |
| Patient's baseline characteristics (selection bias) | High risk | Bodyweight (P = 0.010); body mass index (P = 0.029); waist circumference (P = 0.003). |
| Patient's baseline outcomes (selection bias) | Low risk | SBP (P = 0.165); DBP (P = 0.260); HbA1c (P = 0.999); LDL (P = 0.707). |
| Incomplete outcome data (attrition bias) | High risk | They state that 128 met criteria but only ended up randomising 74, why? Also only 61 completed the trial, but the numbers they provided for loss to follow‐up do not match. There is 1 missing participant from the control group, which they have not accounted for. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Primary outcomes, objective laboratory methods not described. Physicians and investigators were blinded to participant randomisation. Except for physiotherapist who was administering the intervention. However, there was no mention of who collected the data and whether they were blinded. |
| Selective reporting (reporting bias) | Low risk | Checked protocol and everything proposed was completed. |
| Risk of contamination (other bias) | High risk | Individuals in control group could have sought out an exercise programme. |
| Other bias | Low risk | Information not available. |