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. 2018 Apr 17;2018(4):CD010842. doi: 10.1002/14651858.CD010842.pub2
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.
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.
Outcomes At 18 months:
  • pain (WOMAC);

  • function (WOMAC);

  • self‐efficacy (stair climb, 6‐minute walk: 6‐minute walk data only was used to avoid duplication from the same sample, as the 6‐minute walk test is a more widely utilised measure);

  • SF‐36: mental health; social function; emotional role, vitality.

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