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ActivOnline: Physical Activity in Cystic Fibrosis Trial UK (ActiOnPACTUK)

U

University of Exeter

Status

Withdrawn

Conditions

Cystic Fibrosis

Treatments

Behavioral: ActivOnline

Study type

Interventional

Funder types

Other

Identifiers

NCT04249999
1819/04

Details and patient eligibility

About

Increased level of physical activity (PA) are of benefit in the management of cystic fibrosis (CF). This randomised control tial will assess whether three-months use of an online platform can help increase PA levels in people with CF (compared to a control group continuing routine treatment).

Full description

Cystic fibrosis (CF) is a genetic condition that predominantly affects the lungs through an accumulation of thick mucus. As there is no cure for CF, it is a disease that is managed through intensive medication, nutrition, physiotherapy, exercise and physical activity (PA).

Increased levels of PA are of benefit to people with CF, and therefore interventions that promote PA are warranted, particularly in adolescence, whereby PA levels decrease. Telehealth interventions are of particular interest in CF, whereby strict cross-infection guidelines prevent patients meeting in person, and allowing patients to overcome geographical barriers at the same time.

Previous research has shown engagement with an online platform (www.activonline.com.au), specifically designed to monitor PA in CF, is feasible and acceptable to people with CF. Therefore, a full randomised control trial is warranted to assess the efficacy of this intervention in changing PA.

UPDATE JUNE 2021: Due to ongoing restrictions placed upon research by the global COVID-19 pandemic, modifications to the protocol are necessary.

Recruitment and consenting will now take place online, and testing procedures will be completed by participants in their own homes. The nature, and length of, intervention remains unchanged.

Changes to protocol approved by ethics board on May 4th 2021.

Sex

All

Ages

12 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed diagnosis of CF
  • Aged 12-35 years (inclusive)
  • Able to provide informed consent/assent
  • Able to access the internet via computer or mobile device

Exclusion criteria

  • Presence of severe co-morbidity limiting mobilisation or physical activity participation (e.g. orthopaedic, cardiac or neurological condition)
  • Previous lung transplantation
  • Pregnancy
  • Unable to provide informed consent/assent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Intervention
Experimental group
Description:
Access to online physical activity platform (www.activonline.com.au) in addition to usual care.
Treatment:
Behavioral: ActivOnline
Control
No Intervention group
Description:
No access to online physical activity platform. Continue with usual care.

Trial contacts and locations

1

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Central trial contact

Owen W Tomlinson, PhD

Data sourced from clinicaltrials.gov

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