Physical function in older people at risk of mobility disability Other
Conditions
Interventions
The ACE study is an individually randomised, parallel-group, single-blind randomised controlled trial with an internal pilot phase, a whole-systems oriented process evaluation and an economic evaluati
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Short Physical Performance Battery (SPPB) score between 4 and 9 inclusive. This is based on definitions of physical frailty from the European Medicines Agency for identifying people with (or at risk of) physical frailty in clinical trials. This guidance defines pre-frailty as an SPPB score of 8-9 and frailty as an SPPB score of 7 or less 2. Planning to reside in the target area for intervention delivery for at least 18 months
Exclusion criteria
Exclusion criteria: 1. Self-reported inability to walk across a room without help (use of a stick for support is acceptable) 2. Being too physically active (defined by four verbal screening questions (How would you find walking across a room? How easy would you find getting out of a low chair? How easy would you find walking up a flight of stairs with no handrail or wall to lean on? How easy do you find walking on uneven pavement without losing your balance? Responses easy/a little difficult/very difficult) 3. Having an existing major mobility limitation (SPPB of 3 or less) 4. Living in residential or nursing care; e) Having any serious medical conditions that would preclude participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower limb physical function assessed using a Short Physical Performance Battery (SPPB) at baseline, 6 and 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Participants and volunteers: 1. Weekly volume of physical activity accounting for both physical activity intensity and duration, measured using accelerometry at baseline, 6, 12 and 18 months 2. Average number of times a participant transitions from sitting to standing per hour of the day, measured using accelerometry at baseline, 6, 12 and 18 months 3. The number of times a participant transitions from sitting to standing each hour of the day, measured using accelerometry at baseline, 6, 12 and 18 months 4. Average proportion of each waking hour spent in active events, measured using accelerometry at baseline, 6, 12 and 18 months 5. Average proportion of each waking hour spent inactive, measured using accelerometry at baseline, 6, 12 and 18 months 6. Adherence to Chief Medical Officers’ recommendations for strength training exercise measured using Muscle-Strengthening Exercise - Adherence scale at baseline, 6 and 18 months 7. Psychological functioning and well-being measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at baseline, 6, 12 and 18 months 8. Subjective well-being measured using the Ageing-Well Profile at baseline, 6 and 18 months Participants only: 1. Health-related quality of life measured using EQ-5D-5L, ICECAP-O at baseline, 6, 12 and 18 months 2. Capability measured using ICECAP-O at baseline, 6, 12 and 18 months 3. Activities of daily living measured using EQ-5D-5L, ICECAP-O at baseline, 6, 12 and 18 months 4. Medical history, medications, health and social service usage measured using medical history and medications, health and social care usage questionnaires at baseline, 6, 12 and 18 months 5. Frequency of trips out of the house measured using a questionnaire item on trips out of the house (previously used in the OPAL study) at baseline, 6 and 18 months 6. Frequency of falls, injurious falls and fear of falling measured using Falls Inventory, Short Falls-Efficacy scale-international (Short FES-I) at baseline, 6 and 18 m | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed