Adams 2018.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 64 (33 in the intervention group; 31 in the usual activity group) Number analyzed: 64 Number of centers: 2 Date of first enrollment: January 2015 Length of follow‐up: 24 weeks Sample size estimation: the authors aimed to recruit a total of 80 community‐living visually impaired older adults to allow for loss to follow‐up. |
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Participants | Country: UK Age: mean 78 years (range 61 to 95 years) Sex: 39% male, 61% female Key inclusion criteria: having visual impairment, living in own home, walking independently, physically being able to participant in exercise class Key exclusion criteria: unable to understand instructions in English, uncontrolled medical diseases, having conditions requiring a specialist exercise program, unable to maintain upright position, no indoor mobility, included in other fall prevention programs Comparability of baseline characteristics: comparable |
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Interventions |
Behavioral intervention #1: the exercise program (Falls Management Exercise) consisted of one hour weekly sessions over 12 weeks and was held in community venues with a maximum capacity of ten participants per group. The exercises consisted of balance specific, individually‐tailored and targeted training for dynamic balance, strength, endurance, flexibility, gait and functional skills, training to improve ‘righting’ or ‘correcting’ skills to avoid a fall and backward‐chaining i.e. retraining of the ability to get down to and up from the floor. Functional floor exercises and adapted Tai Chi exercises were also carried out with progressively more challenging content over the 12 weeks. Resistance bands and mats were used. Participants were also advised to exercise at home for up to two hours per week. The exercises were to be performed if possible daily, on the days the participant was not attending the exercise class. All home programs contained ‘prompts’ that linked exercises to daily tasks e.g. performing heel raises whilst waiting for the kettle to boil, in order to improve adherence. Exercises were provided in a large text booklet, DVD or audio format. Exercises were designed to be completed in 10 to 20min blocks, become more challenging and graduate into longer periods. Control intervention #2: participants received no intervention and continued with their usual activities. They were offered an equivalent exercise program after the 24 weeks follow‐up. |
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Outcomes | Primary outcome: fear of falling scores at 24 weeks measured by The Short Falls Efficacy Scale ‐ International (SFES‐I). Secondary outcomes: (1) physical activity (self‐reported physical activity questionnaire [Phone‐FITT]), (2) health‐related quality of life (European Quality of Life 15), (3) activity avoidance, (4) time Get Up & Go test, (5) falls risks (Falls Risk Assessment Tool), (6) loneliness (Six‐Item Scale for Overall, Emotional, and Social Loneliness), (7) Home Anxiety and Depression Scale (14 items), (8) Work and Social Adjustment Scale. |
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Notes | Funding sources: Public Health Research Programme of the National Institute for Health Research (NIHR), Health Promotion Interventions for People with Impairment Programme, UK Statistical analyses: appropriate Subgroup analyses: none reported Registration: ISRCTN ID: 16949845 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was stratified by center and was administered centrally via Newcastle Clinical Trials Unit using a secure web based system using a blocked allocation system to allocate participants to the two groups. |
Allocation concealment (selection bias) | Low risk | A blocked allocation (permuted random blocks of variable length) system was used to allocate participants to the two groups (block size will not be disclosed to the investigators) in a 1:1 ratio to intervention and control groups. Participant screening ID, initials and gender were entered into the web‐based system, which would return the allocation status. Participants were informed by telephone, of their allocated treatment group following randomization. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were informed of their allocated treatment group following randomization. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to assess. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 49 out of 64 (92%) participants completed the 24‐week visit (four had withdrawn completely and one was lost to follow up from the study). In two cases, assessments were completed outside the two‐week limit, due to other commitments or extenuating circumstances. All participants in the intervention group remaining in the trial at each time point completed each of the questionnaires. There were two occasions when participants in the usual activity group partially completed a questionnaire, and two occasions on which whole questionnaires were not completed. |
Selective reporting (reporting bias) | High risk | Not all outcomes reported: i.e., activity avoidance, and loneliness. |
Other bias | Low risk | No other sources of bias identified. |