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. 2021 Dec 21;2021(12):CD002008. doi: 10.1002/14651858.CD002008.pub5

Rydwik 2008.

Study characteristics
Methods RCT.
Parallel design with 4 arms.
Duration: 12 weeks intervention, and a further 6 months follow‐up.
Location: Sweden.
Participants Inclusion criteria: frail adults, aged over 75 years with unintentional weight loss > 5% or BMI < 20 kg/m² (or both) and low physical activity level.
Exclusion criteria: under 75 years, BMI > 30 kg/m2, non‐walkers, people with recent cardiac problems requiring hospital care, recent hip fracture or surgery with previous 6 months, CVA within the previous 2 years, score below 7 points on the SF‐MMSE or institutionalisation.
Diagnosis: older people living in the community.
Number randomised: 96 participants (intervention group 1, n = 25; intervention group 2, n = 25; intervention group 3, n = 23; control group, n = 23). Attrition: 32 dropouts (intervention group 1, n = 7; intervention group 2, n = 11; intervention group 3, n = 4; control group, n = 10).
Gender split: 38/96 (40%) males, 58/96 (60%) females.
Age: mean (SD) years intervention group 1, 83.1 (4.5); intervention group 2, 83.1 (4); intervention group 3, 83.5 (3.7); control group, 82.9 (4).
Nutritional status: BMI kg/m2 intervention group 1, 21.8 (3.4); intervention group 2, 21.9 (3.8); intervention group 3, 21.9 (3.8); control group, 21.6 (3.6).
Interventions Intervention 1: participants received dietary advice in the form of dietary counselling to increase energy intake.
Intervention 2: dietary counselling plus exercise training.
Intervention 3: exercise training alone.
Control group: participants received no dietary advice in the form of general physical training advice (30 min per day) and general diet advice (3x main courses and 2 ‐ 3 in‐between meal snacks daily).
Outcomes Weight*, TSF*, fat free mass, energy intake*, muscle strength, physical performance (balance, time‐to‐up‐and‐go, walking speed, chair to stand etc), self‐efficacy.
Publication details Language: English.
Funding: none declared.
Publication status: peer‐reviewed journal.
Notes Data on dietary counselling group and control group will be used.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "subjects were randomised consecutively in batches.....The randomisation procedure was conducted in an open manner".
Insufficient information to make a judgement.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding (performance bias and detection bias)
Clinical outcomes Low risk Blinding not described but assessment of mortality unlikely to be influenced by lack of blinding.
Blinding (performance bias and detection bias)
Functional outcomes Unclear risk No functional outcomes assessed.
Blinding (performance bias and detection bias)
Nutritional outcomes High risk Not stated and likely that some outcomes might be influenced by lack of blinding.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No blinding described and likely that lack of blinding might influence assessment of some outcomes.
Incomplete outcome data (attrition bias)
All outcomes Low risk Fully described 32/96 (33%) dropouts overall: 7/25 (28%) in the dietary counselling group, 11/25 in the dietary counselling plus exercise, 4/23 in the exercise alone group and 10/23 (43%) in the control group.
Judged as low risk because amount of attrition imbalanced between intervention groups (dietary counselling 28% versus control 43%) but the difference not greater than 20%.
Selective reporting (reporting bias) Unclear risk No protocol identified. All specified outcomes reported apart from TSF. The data were requested from the authors but unavailable. Data on mean change in weight and energy intake were reported without SD and so have been obtained from the author.
Other bias Low risk Baseline variables given, groups similar at baseline.