Clinical trial NCT02820571: The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study
Official title: The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 5409
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in the OPAL cohort study will be community dwelling adults, aged 65 years and over, registered with a primary care practice

Brief summary: The OPAL study is about health outcomes in older adults. The investigators are surveying 4,000 adults across England to see how health and physical activity change over time. The information that is collected will help the investigators to understand how a person's health, including conditions such as back pain, affect their mobility as they age, and provide insight into improving the management of health in older adults.

Detailed description: The Oxford Pain, Activity and Lifestyle (OPAL) study is a large cohort study of community dwelling adults (n=4000) aged 65 years and over. This cohort data will allow the investigators to describe the prevalence, severity, course and prognosis a range of musculoskeletal problems in older people. The initial focus is to evaluate the impact of back pain on important health outcomes for older people (quality of life, mobility, falls and fractures). In order to do this, the investigators will study people with and without back pain at the inception of the cohort. The OPAL cohort will be followed for 5 years in the first instance and the investigators will study a range of factors hypothesised to moderate and mediate the effects of back and other musculoskeletal pain for example, co-morbidities.

The OPAL cohort will be sampled from older people registered with primary care practices.

The investigators aim to develop a prognostic tool using the cohort data that will help older people, GPs and other health professionals identify when LBP is a risk factor for disability, functional limitation and loss of mobility, and when LBP should be prioritised as a treatment target.

Eligibility criteria: Inclusion Criteria:

* Registered with a primary care practice.
* 65 years and over.

Exclusion Criteria:

* Living in a residential care or nursing home.
* Has a terminal condition with a life expectancy of less than 6 months.
* 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 e.g. Dementia.

Primary outcomes:
measure: Life-Space assessment
timeFrame: 5 years
measure: Self-reported falls
timeFrame: 5 years
measure: EQ-5D-5L
timeFrame: 5 years
measure: Tilburg Frailty Indicator
timeFrame: 5 years
measure: Health Resource Use
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford, Botnar Research Centre
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Sarah Lamb
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyle S, Williamson E, Darton F, Griffiths F, Lamb SE. A qualitative study of older people's experience of living with neurogenic claudication to inform the development of a physiotherapy intervention. Disabil Rehabil. 2017 May;39(10):1009-1017. doi: 10.1080/09638288.2016.1177611. Epub 2016 May 23.