Background
Methods
Trial design
Study population
Inclusion criteria | Aged 65 years or older and not in full-time employment Planning to reside in the target area (Bath/Bristol, Devon, Birmingham) for at least 24 months Score between 4 and 9 (inclusive) on the Short Physical Performance Battery (SPPB) |
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Exclusion criteria | Self-reported inability to walk across a room without a walker or the help of another person Existing major mobility limitation (defined as SPPB of 3 or less, or unable to complete the 4-m walk component of SPPB) Living in residential or nursing care Inability to attend the REACT physical activity sessions as scheduled A documented or patient-reported medical condition that would preclude participation, including: • Arthritis so severe it would prevent participation in physical activity • Parkinson’s disease or diagnosed dementia • Any terminal illness • Lung disease requiring use of orally administered corticosteroids or supplemental oxygen • Severe kidney disease requiring dialysis • Severe heart disease that would prevent participation in physical activity (e.g. chest pain when walking 100 or 200 yards or up a flight of stairs) • Implanted cardiac defibrillator • Cardiac arrest which required resuscitation • Severe uncontrolled psychiatric illness • Currently receiving radiation therapy or chemotherapy treatment for cancer • Awaiting knee or hip surgery • Major heart surgery (including valve replacement or bypass surgery) in the last 6 months • Unstable heart condition (e.g. uncontrolled arrhythmia, angina, heart failure or hypertension) • Spinal surgery in the last 6 months • Any other clinical condition that the person’s GP or clinician considers would make them unsuitable for participation in a physical activity rehabilitation programme to prevent decline of lower-limb functioning For the MRI sub-study: Contraindications for MRI scanning (assessed using CRIC Bristol Standard Operating Procedure for Screening Subjects for Safety to Scan (Ref MRI Local Rules and Procedures, 2011) History of neurological illness (e.g. stroke) Current treatment for a psychiatric illness Insufficient English to understand what participation entails and provide consent in English |
Temporary exclusion criteria | Heart attack (or myocardial infarction), stroke, spinal surgery, hip fracture, hip or knee replacement within the previous 6 months Currently receiving physical therapy on legs or enrolled in another physical activity research or intervention study |
Recruitment
Primary care
Third-sector organisations
Word-of-mouth and snowball sampling
Local media
Eligibility screening
Consent
Randomisation/allocation
Study intervention
Intervention arm
Control arm
Intervention delivery
Intervention fidelity
Intervention theoretical framework
Assessments
Visit type | Scr11 | Scr22 | FU33 | FU44 | FU55 |
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Visit code | SV1 | F06 | F12 | F24 | |
Visit number | 1 | 2 | 3 | 4 | |
Telephone call | 1 | ||||
Activity/assessment month | − 0.5 | 0 | 6 | 12 | 24 |
Form name | |||||
Verbal consent | X | ||||
Telephone screening (some elements of inclusion and exclusion criteria) (see Additional file 4) | X | ||||
Written informed consent (see Additional file 5) | X | ||||
Contact information update | X | X | X | X | X |
Demographic, social, economic | X | ||||
X | X | X | X | ||
Accelerometry | X | X | X | X | |
Height and weight | X | X | X | ||
MoCA – Montreal Cognitive Assessment [13] | X | X | X | X | |
PASE questionnaire [14] | X | X | X | X | |
Dynometer (hand-grip strength) | X | X | X | X | |
Ageing Well profile (two sites full scale, one site social well-being scale only) [15] | X | X | X | ||
X | X | X | X | ||
Sleep Condition Indicator [18] | X | X | X | ||
Pain (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [19] | X | X | X | ||
Mobility Assessment Tool-short form (MAT-sf) [20] | X | X | X | X | |
Cognitive function (UK Biobank Healthy Minds Questionnaire) [21] | X | X | X | X | |
Medical history including medications, chronic diseases, cardiovascular disease and other conditions | X | ||||
Falls Inventory including falls in last 6 months and injuries relating to falls | X | X | X | X | |
Health and Social Service Usage including use of primary, secondary or community care services in previous 6 months | X | X | X | X | |
(MRI sub-study) MRI scan, detailed cognitive assessment and gait analysis | X | X | X | ||
Process evaluation6 | X | X | |||
Session attendance (intervention group only) | X | X | |||
Total contact time for each participant | X | X | X | ||
Physical activity related self-concept | X | X | X | ||
Perceived tension of maintaining current PA | X | X | X | ||
Perceived tension of maintaining current exercise | X | X | X | X | |
Autonomy in relation to PA | X | X | X | X | |
Competence for PA | X | X | X | X | |
Relatedness for PA | X | X | X | X | |
Enjoyment of PA | X | X | X | X | |
Perceived intrinsic benefits of PA (social, physical and emotional) | |||||
Autonomy for strength-building exercise | X | X | X | X | |
Competence for strength-building exercise | X | X | X | X | |
Relatedness for strength-building exercise | X | X | X | X | |
Enjoyment of strength-building exercise | X | X | X | X | |
Perceived intrinsic benefits of strength-building exercise (social, physical and emotional) | X | X | X | X | |
Enjoyment of the REACT programme (intervention group) | X | X | |||
Credibility/identification with the session facilitators (intervention group only) | X | X |
Sample size calculation
Statistical analysis
Subgroup analyses
Adjusted analysis
MRI imaging sub-study
Primary and secondary outcome data analysis
Data presentation and analysis models
Model assumptions
Subgroup analyses
Economic evaluation
Process evaluation
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Evaluate the feasibility of implementation, including barriers and facilitators, to inform future implementation and possible refinements of the intervention
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Evaluate the quality and quantity of intervention delivery to inform conclusions about intervention effectiveness
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Investigate the proposed mechanisms of change, outlined in the REACT logic model (Additional file 3: Figure S1) and seek alternative explanations if this model is not supported
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Understand the role of context to inform whether and how the findings can be generalised