NCT04249999

Brief Summary

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 7, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

November 13, 2019

Last Update Submit

September 16, 2024

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

  • Change in physical activity, objectively measures using ActiGrpah GT9X Link accelerometer.

    Time spent in sedentary, light, moderate and vigorous physical activity domains will be assessed over a one week period. Accelerometer to be worn on non-dominant wrist.

    Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).

  • Change in physical activity, subjectively measured using the Habitual Activity Estimation Scale.

    Questionnaire determines time spent being inactive, somewhat inactive, somewhat active and very active, each reported as a percentage of the day.

    Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).

Secondary Outcomes (10)

  • Change in forced expiratory volume in one second (FEV1), measured in absolute units (L)

    Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).

  • Change in forced vital capacity (FVC), measured in absolute units (L)

    Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).

  • Change in forced expiratory volume in one second (FEV1), measured as a percent of predicted, as per GLI2012 equations.

    Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).

  • Change in forced vital capacity (FVC), measured as a percent of predicted, as per GLI2012 equations.

    Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).

  • Change in exercise attitudes, measured using the Behavioural Regulation in Exercise Questionnaire.

    Baseline, post-intervention (+12 weeks), 3-months post-intervention (+24 weeks).

  • +5 more secondary outcomes

Other Outcomes (5)

  • Qualitative assessment of barriers and facilitators to physical activity

    3-months post-intervention (+24 weeks)

  • Qualitative assessment of Activ Online programme

    3-months post-intervention (+24 weeks)

  • Usage of Activ Online programme

    Post-intervention (+12 weeks)

  • +2 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: ActivOnline

Control

NO INTERVENTION

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

Interventions

ActivOnlineBEHAVIORAL

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

Intervention

Eligibility Criteria

Age12 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (3)

  • Cox NS, Alison JA, Button BM, Wilson JW, Holland AE. Feasibility and acceptability of an internet-based program to promote physical activity in adults with cystic fibrosis. Respir Care. 2015 Mar;60(3):422-9. doi: 10.4187/respcare.03165. Epub 2014 Nov 25.

    PMID: 25425703BACKGROUND

  • Cox NS, Eldridge B, Rawlings S, Dreger J, Corda J, Hauser J, Button BM, Bishop J, Nichols A, Middleton A, Ward N, Dwyer T, Tomlinson OW, Denford S, Barker AR, Williams CA, Kingsley M, O'Halloran P, Holland AE; Youth Activity Unlimited - A Strategic Research Centre of the UK Cystic Fibrosis Trust. A web-based intervention to promote physical activity in adolescents and young adults with cystic fibrosis: protocol for a randomized controlled trial. BMC Pulm Med. 2019 Dec 19;19(1):253. doi: 10.1186/s12890-019-0942-3.

    PMID: 31856791BACKGROUND

  • Tomlinson OW, Barker AR, Denford S, Williams CA. Adapting, restarting, and terminating a randomised control trial for people with cystic fibrosis: Reflections on the impact of the COVID-19 pandemic upon research in a clinical population. Contemp Clin Trials Commun. 2024 Mar 27;39:101294. doi: 10.1016/j.conctc.2024.101294. eCollection 2024 Jun.

    PMID: 38577655RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Craig A Williams, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

January 31, 2020

Study Start

May 7, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)