ActivOnline: Physical Activity in Cystic Fibrosis Trial UK

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-07

Study Completion Date

2021-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Trial of ExACT (Exercise as Airway Clearance Therapy) for People With Cystic Fibrosis

NCT05482048

Cystic Fibrosis

ACTIVE_NOT_RECRUITING NA

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT06616857

Cystic Fibrosis (CF)

RECRUITING NA

Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis

NCT00231686

Cystic Fibrosis

COMPLETED PHASE2/PHASE3

Extrapulmonary Effects of Cystic Fibrosis on Physical Activity of Adult Patients.

NCT01848392

Cystic Fibrosis

COMPLETED

Combined Effect of CFTR Protein Modulator Drugs and Exercise in Cystic Fibrosis

NCT04415268

Cystic Fibrosis in Children

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Physical activity intervention. Assignment to intervention or control group cannot be blinded.

Follow-up assessments will be conducted by blinded assessors.

UPADTE JUNE 2021: As noted in update above, all participants will perform procedures themselves within their own homes (i.e. physical activity, lung function, questionnaires). Therefore, use of blinded assessors is no longer applicable.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Access to online physical activity platform (www.activonline.com.au) in addition to usual care.

Group Type EXPERIMENTAL

ActivOnline

Intervention Type BEHAVIORAL

Access to online physical activity platform (www.activonline.com.au)

Control

No access to online physical activity platform. Continue with usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ActivOnline

Access to online physical activity platform (www.activonline.com.au)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No