Low levels of physical activity Not Applicable
Conditions
Interventions
The study will compare ‘usual practice’ (NERS) with an enhanced exercise referral group (NERS+MyWellnessKey).
Control treatment (NERS)
The control group will receive s
a 16-week structured exercise programme. Scheme participants receive a consultation with an exercise professional which includes collection of routine monitoring data, introduction to the facilities,
MWK] to be used for self-monitoring of physical activity levels in combination with a linked web platform [MyWellnessCloud] and smartphone application. The MWK has been validated in terms of device ac
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. The following measures will be collected at baseline, 16 weeks and 12 months: 1. Body Mass Index (calculated from height and weight) 2. Waist circumference 3. Blood pressure and resting heart rate 4. Fitness level (measured using Chester fitness test) 5. Health-related quality of life (measured using EQ-5D-5L47) 6. Autonomous motivation (measured using Behavioural Regulations in Exercise Questionnaire) | — |
Countries
United Kingdom, Wales
Outcome results
None listed