Physical activity monitors in the Welsh National Exercise Referral Scheme to enhance maintenance

Not Applicable

Completed

• Conditions: ow levels of physical activity; Not Applicable

• Registration Number: ISRCTN85785652
• Lead Sponsor: Cardiff University

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29238607 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30924791 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-05
• Study Completion: 2017-09-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Individuals referred into the National Exercise Referral Scheme generic pathway identified as having capacity to use the activity monitors (i.e. computer access and an email address).

For referral into the scheme, patients must:
1. Be aged 16 years or above
2. Be sedentary (defined as not moderately active for 3 times per week or deconditioned through age or inactivity)
3. Have at least one of the following:
3.1. Raised blood pressure 140/90
3.2. BMI >28
3.3. Cholesterol >5.0
3.4. Controlled diabetes or impaired glucose intolerance
3.5. Family history of heart disease or diabetes
3.6. At risk of osteoporosis or musculoskeletal pain
3.7. Mild arthritis or poor mobility
3.8. Mild-moderate COPD
3.9. Mild anxiety or depression
3.10. Multiple sclerosis

Exclusion Criteria

Individuals not referred to the NERS generic pathway and/or without computer access and an email address.

Exclusion criteria for referrals include:
1. Cardio-myopathy
2. Suspected or known aneurysm
3. Unstable or acute heart failure
4. Established coronary heart disease
5. Various uncontrolled conditions (hypertension 180/100, resting tachycardia 100bpm, diabetes, angina, epilepsy, arrhythmias, and psychiatric illness)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In this pilot trial, primary outcomes are focused on feasibility and acceptability of the intervention and trial methods. We will also pilot planned primary and secondary outcomes in order to assess responsivity and sensitivity to change for a full trial. We will collect data on the potential range of effect sizes associated with the intervention. This data will be used to calculate a sample size for a subsequent full effectiveness trial, if warranted. The primary outcome in the pilot trial used to inform the sample size calculation will be physical activity at 16 months.

Secondary Outcome Measures

Name	Time	Method
<br> We will evaluate the effect of the intervention on the main hypothesised change mechanism (autonomous motivation) at 12-month follow-up. We will also pilot secondary outcome measures to estimate key trial parameters (e.g. standard deviation) to inform a future full trial, these are: fitness level, resting heart rate, blood pressure, waist circumference, body mass index, health-related quality of life and a cost-utility analysis.<br><br> The following measures will be collected at baseline, 16 weeks and 12 months:<br> 1. Body Mass Index (calculated from height and weight)<br> 2. Waist circumference<br> 3. Blood pressure and resting heart rate<br> 4. Fitness level (measured using Chester fitness test)<br> 5. Health-related quality of life (measured using EQ-5D-5L47)<br> 6. Autonomous motivation (measured using Behavioural Regulations in Exercise Questionnaire)<br>