NCT03462654.
| Trial name or title | Comparison of a group‐delivered and individually‐delivered lifestyle‐integrated functional exercise (LiFE) programme in older persons |
| Methods | RCT |
| Participants | Target sample size: 300 participants Inclusion criteria: Aged 70 years or older; speaks German; able to read newspaper; able to walk 200 meters with or without walking aid; home‐dwelling; 2 or more falls in the past 12 months OR 1 injurious fall in the past 12 months OR subjective decline in balance and strength in the past 12 months together with Timed Up and Go Test time > 13.5 seconds; available for intervention participation for 11 weeks Exclusion criteria: Cognitive impairment (MoCA < 23); current participation in an organised exercise class > 1 a week in the past 3 months; moderate‐ to vigorous‐intensity physical activity ≥ 150 minutes a week in the past 3 months; a list of 8 medical conditions |
| Interventions | 1. Individual LiFE (iLiFE). In iLiFE, LiFE activities to increase strength, improve balance, and promote physical activity as well as habitualisation strategies are introduced and taught in 7 highly individualised, one‐to‐one home visits 2. Group LiFE (gLiFE). In gLiFE, the same LiFE activities as performed in iLiFE are introduced and taught in 7 group sessions with 8 ‐ 12 participants. Implementation and habitualisation strategies will be addressed within the group setting, making use of group dynamics and processes |
| Outcomes | 1. Fall incidence expressed as number of falls per amount of physical activity 2. Cost‐effectiveness of iLiFE and gLiFE (incremental cost‐effectiveness ratios (ICERs) of delivering iLiFE and gLiFE) |
| Starting date | April 2018 |
| Contact information | Carl‐Philipp Jansen Heidelberg University, Network Aging Research, GERMANY ph. +49 6221 548144 Email: jansen@nar.uni‐heidelberg.de |
| Notes |
ADL: activities of daily living m: metres MMSE: Mini Mental State Examination RCT: randomised controlled trial SD: standard deviation TUG: Timed Up and Go test wk: week x: times <: less than >: more than ≥: greater than or equal to