Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/02/2020
Date assigned
24/02/2020
Last edited
24/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cystic fibrosis (CF) is a genetically inherited disease that primarily affects the lungs and digestive system.

Ireland has the highest incidence of CF in the world with 1 in every 19 Irish people carrying one copy of the defective gene that causes CF. Treatments that help people with cystic fibrosis improve health, ease symptoms, and increase life expectancy include daily medications, physiotherapy, respiratory training, and nutrition. Symptoms of the disease can make it difficult for people with CF to engage in regular physical activity. However, regular physical activity can reduce medical problems and have a significant impact on improving a patient’s quality of life and life expectancy. The benefits of physical activity in patients with CF include increased exercise tolerance, respiratory muscle endurance and sputum expectoration (ejecting phlegm or mucus from the throat or lungs by coughing, hawking, or spitting), reduced rate of decline in lung function, improvements in fluid balance and retention of serum electrolytes, as well as lower risk of death.

Although physical activity is a well-established mode of therapy for people with CF, there is a large gap in our understanding of what constitutes the optimal exercise program for improving functional capacity and optimizing health-related quality of life and life expectancy. Ideally, exercise programs should be enjoyable, easily incorporated into day-to-day life, connect people with cystic fibrosis with friends and family, and improve quality of life.

The purpose of this study is to design, implement and evaluate the efficacy of a 12-week cystic fibrosis-specific, partially supervised and self-regulated exercise intervention on functional capacity and health-related quality of life. Following the intervention, the exercise group will be invited to participate in a feedback interview, to further evaluate the efficacy of the program.

Who can participate?
Adults with Cystic Fibrosis

What does the study involve?
Participants will be allocated randomly to either be in the exercise or no change groups.

Participants will make two visits, separated by 7 days, to the testing site before they start the exercise program for a series of physical and psychological assessments. Participants will wear an accelerometer for the 7 day period between these visits to assess physical activity and sedentary behaviour.

Participants in the exercise group will also receive an exercise manual (hardcopy) and access to an online exercise diary for a 12 week period. Over this period, the exercise group will receive a Fitbit device, to track daily steps and active minutes.

After the 12 weeks of either the exercise program or no change, participants will make another two visits, separated by 7 days, to the testing site where they will complete the same series of physical and psychological assessments. Participants will again wear an accelerometer for the 7 day period between these visits to assess physical activity and sedentary behaviour.

What are the possible benefits and risks of participating?
Benefits: Participants will receive a copy of their results in a report format, summarizing information such as body composition, pulmonary function score, muscular strength and cardiovascular fitness.
Risks: Exercise carries with it a very small risk of abnormal heart rhythms, heart attack, or death in less than one in 30,000 patients. In patients with established chronic illness the risk is higher. The yearly incidence of cardiac arrhythmias during exercise testing and physical conditioning in people with CF was 0-0.1% and matches that of the healthy population. An emergency room and automated external defibrillator (AED) are available onsite. The research team are appropriately qualified and experienced working with clinical populations in a safe and professional manner.

Where is the study run from?
Dublin City University (Ireland)

When is the study starting and how long is it expected to run for?
January 2020 to July 2020

Who is funding the study?
Cystic Fibrosis Ireland and The Mater Foundation (Ireland)

Who is the main contact?
Miss Nicola Hurley
nicola.hurley5@mail.dcu.ie

Trial website

Contact information

Type

Public

Primary contact

Miss Nicola Hurley

ORCID ID

http://orcid.org/0000-0002-2394-4472

Contact details

XB26
Lonsdale Building
Dublin City University
Glasnevin
Dublin
9
Ireland
+353 017008470
nicola.hurley5@mail.dcu.ie

Type

Scientific

Additional contact

Miss Nicola Hurley

ORCID ID

http://orcid.org/0000-0002-2394-4472

Contact details

XB26
Lonsdale Building
Dublin City University
Glasnevin
Dublin
9
Ireland
+353 017008470
nicola.hurley5@mail.dcu.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

An evaluation of the efficacy of a 12-week partially supervised, self-regulated exercise intervention on physiological and psychometric indices in patients with cystic fibrosis: a randomized-controlled trial

Acronym

CF-Ex

Study hypothesis

The partially supervised, self-regulated exercise programme will enhance functional capacity and quality of life in patients with cystic fibrosis

Ethics approval

Approved 07/01/2020, Dublin City University Research Ethics Committee (Research and innovation support, Dublin City University, Dublin 9, Ireland; +35317008000; research@dcu.ie), ref: DCUREC/2019/186

Study design

Single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Cystic Fibrosis

Intervention

Participants will make two visits, separated by 7 days, to the testing site (DCU) at baseline and post-intervention for a series of physiological and psychometric assessments. Participants will wear an accelerometer for the 7 day period between visits to assess physical activity and sedentary behaviour at baseline and post-intervention.

Participants will be randomized (1:1) into intervention (exercise) or control (usual care) groups upon completion of visit 2 at baseline.

The exercise arm will receive a Fitbit device, to objectively track daily steps and active minutes, to wear for the 12-week intervention period. Participants in the exercise group will also receive an exercise manual (hardcopy) and access to an online exercise diary.

The control arm will continue with usual care.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Cardiorespiratory fitness measured using cardiopulmonary exercise test with monitoring of ventilatory gases, heart rate (ECG), blood pressure and oxygen saturation at baseline and 12 weeks

Secondary outcome measures

1. Anthropometry measured using a stadiometer, electronic scales, bioelectrical impedance and waist-to-hip ratio conducted using tape-measurements at baseline and 12 weeks
2. Muscle strength measured using sit-to-stand and biodex isokinetic dynamometry for lower extremity strength and hand-grip dynamometry for upper body strength at baseline and 12 weeks
3. Pulmonary function assessed using spirometry (EasyOne Air device) at baseline and 12 weeks
4. Physical activity assessed using accelerometry (ActivPAL) at baseline and 12 weeks
5. Quality of life evaluated using a CF-specific questionnaire (CFQ-R) at baseline and 12 weeks

Overall trial start date

09/09/2019

Overall trial end date

09/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Established diagnosis of cystic fibrosis (positive sweat chloride or genetic identification test)
2. Residing in the Republic of Ireland
3. ≥ 18 years of age
4. Lung function scores of ≥ 50% predicted
5. Must not have undergone lung transplantation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 participants

Participant exclusion criteria

1. Undergone lung transplantation
2. Culturing MRSA, NTM or Burkholderia Cepacia

Recruitment start date

07/01/2020

Recruitment end date

30/04/2020

Locations

Countries of recruitment

Ireland

Trial participating centre

Dublin City University
Glasnevin
Dublin
9
Ireland

Sponsor information

Organisation

Dublin City University

Sponsor details

Glasnevin
Dublin
9
Ireland
+353 1 700 5000
registry@dcu.ie

Sponsor type

University/education

Website

https://www.dcu.ie/

Funders

Funder type

Charity

Funder name

Cystic Fibrosis Ireland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Mater Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD Sharing statement:
The datasets generated and/or analyzed during this study will be included in the subsequent results publication

Intention to publish date

09/07/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/02/2020: Internal review. 07/02/2020: Trial’s existence confirmed by Dublin City University Research Ethics Committee.