Hip and knee osteoarthritis in people aged over 80 years who also have other illnesses Musculoskeletal Diseases
Conditions
Interventions
TEMPO is a feasibility randomised controlled trial, with an embedded qualitative study, assessing a 12-week tailored exercise intervention versus usual care for adults aged 80 years and over with hip/
via the Oxford Pain, Activity and Lifestyle (OPAL) cohort study (an existing questionnaire study over people aged 65 and over from across England), and via NHS physiotherapy referrals.
Identified pot
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient participants: 1. Aged 80 years and above 2. Clinical diagnosis of knee or hip OA: knee or hip joint pain lasting 3 months or longer AND knee or hip joint pain on most days of the past month 3. Diagnosis of at least one comorbidity (determined by GP record review and/or self-report) 4. Registered with a primary care practice 5. Willing and able to give informed consent for participation in the study Qualitative study: There are no specific exclusion criteria for the qualitative study. If a patient participant has been recruited to the TEMPO study and meets the inclusion criteria they are eligible for the qualitative study. TEMPO physiotherapist interview participants: All physiotherapists who deliver the TEMPO intervention (approximately six physiotherapists) will be eligible to participate in the qualitative interviews. Physiotherapists will be selected by local sites to deliver the TEMPO intervention. To be eligible to deliver the TEMPO intervention physiotherapists must be Band 6 or above. There are no additional eligibility criteria for the qualitative interviews.
Exclusion criteria
Exclusion criteria: Patient participants: 1. Has a terminal condition with a life expectancy of fewer than 6 months or under palliative care 2. Any substantial health or social concern that, in the opinion of the patient’s GP, would place the patient at increased risk or inability to participate including known inability to provide informed consent 3. Unable to walk 3 m with or without an aid 4. Significant cognitive impairment (Score of 8 or more on the 6-item Cognitive Impairment Test) 5. Unable to follow verbal or written instructions including inability to follow simple safety instructions TEMPO physiotherapist interview participants: There are no exclusion criteria for physiotherapists who have delivered the TEMPO intervention taking part in the interview study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient recruitment to the study and retention in the study is measured using study recruitment screening logs: (number of patients who are screened, eligible consented and randomised) and logs of data collection forms (attrition rate), at screening, baseline and 14-week follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient participant engagement with the study and feasibility of the interventions from patient participant and physiotherapist perspectives: 1. Patient participant engagement is measured by physiotherapy session attendance, home exercise adherence (measured by exercise diaries), treatment/s received by usual care group, attrition rate, qualitative interviews, measured during the intervention period and on completion of the qualitative interviews 2. Intervention fidelity assessed by treatment logs, quality assurance visits and safety reporting forms, measured throughout the intervention period 3. Completion of the expected primary outcome measure for a future definitive trial: self-reported physical function measured using the Nottingham Extended ADL Scale (NEADL), measured at the end of the study (to estimate the sample size calculation for a definitive trial) 4. Experiences and perceptions of the study design from a patient participant and physiotherapist perspective, assessed by qualitative interviews at the end of the study | — |
Countries
England, United Kingdom
Outcome results
None listed