Evaluation of the effectiveness of MedEx Wellness

ISRCTN	ISRCTN10351412
DOI	https://doi.org/10.1186/ISRCTN10351412
Protocol serial number	N/A
Sponsor	Health Service Executive
Funder	Health Service Executive

Submission date: 01/12/2015
Registration date: 26/01/2016
Last edited: 21/07/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
It is well known that exercise has a beneficial effect on health. Many studies have shown that taking part in regular physical activity can help to improve the health of people suffering from long-term (chronic) illnesses, by strengthening the heart, lowering blood pressure and maintaining a healthy weight. MedEx Wellness is a new community-based chronic illness rehabilitation programme, which offers medically supervised physical activity classes to patients with a range of chronic illness. Currently, classes are provided to patients with cardiovascular disease (heart and blood vessel disease), pulmonary disease (lung disease), diabetes and cancer. MedEx is unique in that it combines rehabilitation for all of these different chronic conditions into one programme, making the roll-out of the MedEx model throughout the country a real opportunity. The MedEx model could potentially become the standard model used for chronic illness rehabilitation throughout Ireland. The aim of this study is to test the effectiveness of the MexEd programme at improving the physical and mental wellbeing of patients with a range of different chronic illnesses.

Who can participate?
Adults suffering from established cardiovascular disease, pulmonary disease, diabetes or cancer

What does the study involve?
Before beginning the MedEx programme, they are asked to attend Dublin City University for three days of testing. On the first visit, participants have a blood sample taken, height, weight, waist and hip circumference measured; complete a questionnaire and some simple tests of strength and flexibility. They are also given a device to wear on their leg for 7 days to monitor their physical activity. On the second visit, participants perform attention and memory tests, a 6 minute walk test (to test how well their body copes with exercise), and set goals for their exercise programme. Participants are also provided with blood pressure monitor to wear for 24 hours. On the third visit, participants take part in a beginner exercise class as well as having specific tests about how their bodies cope with exercise related to their specific conditions (e.g. patients with lung problems will have lung function tests). After the testing visits, participants being the MedEx programme, which involves attending 2 exercise sessions a week for 12 months. At 3, 6 and 12 months, participants repeat the initial tests in order to see whether the exercise programme is having any effect on their weight and general health.

What are the possible benefits and risks of participating?
As well as the general health benefits of taking part in physical activity, participants may benefit from improved knowledge about the best amount of exercise for people living with chronic conditions, and how best to achieve this. Participants will also benefit from meeting other people in similar situations to themselves and will be provided with a supportive and safe environment in which they can exercise. There is a risk of muscle soreness and tiredness from taking part in the exercise sessions, as well as the possibility of pain or bruising from the blood tests.

Where is the study run from?
MedEx Wellness, Dublin City University Sports Complex (Ireland)

When is the study starting and how long is it expected to run for?
September 2015 to March 2018

Who is funding the study?
Health Service Executive (Ireland)

Who is the main contact?
Dr Noel McCaffrey

Contact information

Dr Noel McCaffrey
Scientific

School of Health and Human Performance
Dublin City University
Glanevin
Dublin 9
D09 W6Y4
Ireland

Study information

Primary study design	Interventional
Study design	Single-centre single-arm intervention pre-post comparison study
Secondary study design	Single arm intervention pre-post comparisons
Study type	Participant information sheet
Scientific title	Evaluation of the MedEx Wellness programme as a public health model for community-based chronic illness rehabilitation
Study objectives	MedEx Wellness will significantly improve physical and psychological wellbeing in patients with a diverse range of chronic illnesses.
Ethics approval(s)	Dublin City University Research Ethics Committee, 06/01/15, ref: DCUREC2014/227
Health condition(s) or problem(s) studied	Chronic illness, primarily: 1. Cardiovascular disease 2. Peripheral arterial disease 3. Pulmonary disease (including chronic obstructive pulmonary disease, pulmonary fibrosis) 4. Diabetes 5. Cancer
Intervention	All participants will attend DCU for 3 days of testing. On Day 1 participants will have a blood sample taken, height, weight, waist and hip circumference measured, complete a questionnaire and some simple tests of strength and flexibility. Participants will be provided with a device to wear on your leg for 7 days to measure physical activity. On Day 2 participants will perform attention and memory tests, a 6min walk test, and set goals for your exercise programme. Participants will be provided with blood pressure monitor to wear for 24 hours. On Day 3 participants will take part in a beginner exercise class and some participants will perform tests – participants with claudication will perform a treadmill test, participants with lung conditions will perform lung function tests, and participants at risk of falling will perform a balance test. After testing, all participants will begin the MedEx programme, which involves two medically supervised exercise classes per week for 12 months. Classes are 60 min and consist of a combination of aerobic and resistance exercise. Specifically, the class format comprises of: 1. Warm-up: 10 minutes of aerobic exercise and range of motion exercises 2. Aerobic exercise: Using cycle ergometers, treadmills, elliptical machines to accumulate 20 minutes of exercise through a mixture of short (~5 minute) and long (~10 minute) intervals. Participants are instructed to exercise at a moderate intensity at which they feel modestly breathless and perspire. 3. Resistance exercise: A circuit of 8-10 stations alternating upper and lower body exercises using both cable machines and light hand weights. Participants are instructed to select an intensity to allow them to perform continuous repetitions for 60 seconds at each station. The circuit is completed twice. 4. Cool down: 10 minutes of aerobic exercise and range of motion exercises
Intervention type	Behavioural
Primary outcome measure(s)	Cardiorespiratory fitness measured using the 6 minute walk test at baseline, 3, 6 and 12 months.
Key secondary outcome measure(s)	1. Quality of life measured using Medical Outcomes Study Short Form-12 and disease specific measures (COPD Assessment Tool, Functional Assessment of Cancer Therapy, Walking Impairment Questionnaire) at baseline, 3, 6 and 12 months 2. Daily physical activity measured using accelerometry and the International Physical Activity Questionnaire at baseline, 3, 6 and 12 months 3. Health care utilisation measured using at baseline from patient records and throughout the trial using a healthcare utilisation diary at baseline, 3, 6 and 12 months 4. Blood pressure using a 24 h ambulatory blood pressure monitor at baseline, 3, 6 and 12 months 5. Lipids measured by a blood sample at baseline, 3, 6 and 12 months 6. Body composition measured using body mass index and waist-to-hip ratio at baseline, 3, 6 and 12 months 7. Strength measured using the sit-to-stand test and handgrip test at baseline, 3, 6 and 12 months 8. Flexibility measured using the sit-and-reach test at baseline, 3, 6 and 12 months 9. Cognitive function measured using the cognitive reserve questionnaire, the Attention Network Task and the Luck and Vogel Visual Working Memory Task at baseline, 3, 6 and 12 months 10. Claudication time measured by the Gardner claudication treadmill test at baseline, 3, 6 and 12 months 11. Respiratory function measured by spirometry at baseline, 3, 6 and 12 months 12. Falls risk measured using the Timed Up and Go Test at baseline, 3, 6 and 12 months
Completion date	01/02/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	104
Key inclusion criteria	1. Aged 18 years or over 2. Established non-communicable disease
Key exclusion criteria	1. Uncontrolled cardiovascular conditions 2. Significant musculoskeletal or neurological conditions, cognitive decline, mental illness or intellectual disability that restricts participation in a physical training programme
Date of first enrolment	25/09/2015
Date of final enrolment	25/09/2016

Locations

Countries of recruitment

Ireland

Study participating centre

MedEx Wellness

DCU Sports Complex
Dublin City University
Collins Avenue Extension
Dublin
D09 W6Y4
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/06/2020	21/07/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/07/2020: Publication reference added.
22/10/2018: The overall trial end date was updated from 31/03/2018 to 01/02/2019.