Methods | 3‐armed randomised controlled trial. | |
Participants |
Inclusion criteria: radiographic evidence of tibiofemoral OA as determined by a single observer on the basis of weight‐bearing anteroposterior radiographs; aged > 60 years,; BMI > 28; engaging in < 20 minutes formal exercise a week; difficulty with ≥ 1 of the following activities due to knee pain: walking 0.25 miles, climbing stairs, bending, stooping, kneeling, shopping, house cleaning, getting in or out of bed, standing up from a chair, lifting and carrying groceries, or getting in or out of a bathtub; willingness to undergo testing and intervention procedures. Exclusion criteria: medical condition that precluded safe participation in an exercise programme, mental score < 28; inability to complete the 18‐month study or unlikely to be compliant; inability to walk without a walking stick or other assistive device; participation in another research study; excessive alcohol consumption; or inability to complete the trial protocol, in the opinion of the clinical staff, because of frailty, illness or other reasons. Country: USA. Sample number: IGa: 76; IGb: 80; CG: 78. Mean age: 69 years Progress Plus: 74% women, 22% non‐white, 88% post 16 or higher education (e.g. vocational/college); Income: 19% < USD15,000; 33% USD15,000‐USD35,000; 23% USD35,000‐USD50,000; 26% > USD50,000. |
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Interventions |
Provider(s): not stated. Training: yes. Setting: facility and home. Length/intensity: 3 times a week for 18 months. Intervention content: IGa: exercise (strength/resistance/aerobic) and diet; IGb: exercise (strength/resistance/aerobic). Control: attention control; healthy lifestyle education. |
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Outcomes | At 18 months:
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Notes | There are 2 Focht 2005 lines in some analyses: first indicated IGa and second indicated IGb. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated block randomisation stratified by race. |
Allocation concealment (selection bias) | High risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not clear and unlikely that participants or providers were aware of group allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of staff to the treatment assignment of the participants. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition: IGa: 23.7% (18/76); IGb: 20% (16/80); CG: 14% (11/78). Reasons for withdrawal not specified. ITT analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Low risk | No other bias detected |