RCT of a complex intervention by primary care nurses to increase walking in patients aged 60-74 years (PACE-Lift Pedometer Accelerometer Consultation Evaluation trial)

Phase 2

Completed

• Conditions: Generic Health; Not Applicable

• Registration Number: ISRCTN42122561
• Lead Sponsor: St George's University of London (United Kingdom)

Brief Summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23289648 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25689364 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26654223 2019 results in: http://www.ncbi.nlm.nih.gov/pubmed/31237875 (added 27/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-21
• Study Completion: 2012-09-30
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Registered at one of the 3 practices recruited into the trial (in Oxfordshire or Berkshire)
2. Age 60-74 years and able to walk outside the home
3. Male or female

Exclusion Criteria

1. Living in a residential or nursing home
2. Housebound
3. Dementia or significant cognitive impairment (unable to follow simple instructions)
4. Three falls in last year or fall in previous year requiring medical attention
5. Terminal illness
6. Registered blind
7. New onset chest pain
8. Myocardial infarction
9. Angioplasty or coronary artery bypass graft in the last 3 months
10. Medical or psychiatric condition which the GP considers as exclusion criteria for the patient:
10.1. Acute systemic illness such as pneumonia
10.2. Acute rheumatoid arthritis
10.3. Unstable or acute heart failure
10.4. Significant neurological disease or impairment
10.5. Unable to move independently,
10.6. Psychotic illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Change in accelerometer step-count at 3 months<br> 2. Change in average daily steps (primary outcome) and average time spent in at least moderate intensity PA weekly at 3 months (main outcome) and 12 months (for maintenance)<br> 3. Self-reported PA, depression scores, pain, quality of life and body size variables will also be assessed<br> 4. A qualitative evaluation will explore the intervention?s acceptability and perceived barriers and benefits to increasing PA<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures