Header

UZH-Logo

Maintenance Infos

Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol


Hebestreit, Helge; Lands, Larry C; Alarie, Nancy; Schaeff, Jonathan; Karila, Chantal; Orenstein, David M; Urquhart, Don S; Hulzebos, Erik H J; Stein, Lothar; Schindler, Christian; Kriemler, Susi; Radtke, Thomas (2018). Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol. BMC Pulmonary Medicine, 18(1):31.

Abstract

BACKGROUND
Physical activity (PA) and exercise have become an accepted and valued component of cystic fibrosis (CF) care. Regular PA and exercise can positively impact pulmonary function, improve physical fitness, and enhance health-related quality of life (HRQoL). However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labour intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 s (FEV) at 6 months in a large international group of CF patients. Secondary endpoints include patient reported HRQoL, as well as levels of anxiety and depression, and control of blood sugar.

METHODS/DESIGN
It is planned that a total of 292 patients with CF 12 years and older with a FEV ≥ 35% predicted shall be randomised. Following baseline assessments (2 visits) patients are randomised into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counselling to increase vigorous PA by at least 3 h per week on each clinic visit, the intervention group documents daily PA and inactivity time and receives a step counter to record their progress within a web-based diary. They also receive monthly phone calls from the study staff during the first 6 months of the study. After 6 months, they continue with the step counter and web-based programme for a further 6 months. The control group receives standard care and keeps their PA level constant during the study period. Thereafter, they receive the intervention as well.

DISCUSSION
This is the first large, international multi-centre study to investigate the effects of a PA intervention in CF with motivational feedback on several health outcomes using modern technology. Should this relatively simple programme prove successful, it will be made available on a wider scale internationally.

TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01744561 ; Registration date: December 6, 2012.

Abstract

BACKGROUND
Physical activity (PA) and exercise have become an accepted and valued component of cystic fibrosis (CF) care. Regular PA and exercise can positively impact pulmonary function, improve physical fitness, and enhance health-related quality of life (HRQoL). However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labour intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 s (FEV) at 6 months in a large international group of CF patients. Secondary endpoints include patient reported HRQoL, as well as levels of anxiety and depression, and control of blood sugar.

METHODS/DESIGN
It is planned that a total of 292 patients with CF 12 years and older with a FEV ≥ 35% predicted shall be randomised. Following baseline assessments (2 visits) patients are randomised into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counselling to increase vigorous PA by at least 3 h per week on each clinic visit, the intervention group documents daily PA and inactivity time and receives a step counter to record their progress within a web-based diary. They also receive monthly phone calls from the study staff during the first 6 months of the study. After 6 months, they continue with the step counter and web-based programme for a further 6 months. The control group receives standard care and keeps their PA level constant during the study period. Thereafter, they receive the intervention as well.

DISCUSSION
This is the first large, international multi-centre study to investigate the effects of a PA intervention in CF with motivational feedback on several health outcomes using modern technology. Should this relatively simple programme prove successful, it will be made available on a wider scale internationally.

TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01744561 ; Registration date: December 6, 2012.

Statistics

Citations

Dimensions.ai Metrics
3 citations in Web of Science®
5 citations in Scopus®
Google Scholar™

Altmetrics

Downloads

17 downloads since deposited on 04 Jan 2019
17 downloads since 12 months
Detailed statistics

Additional indexing

Contributors:ACTIVATE-CF Study Working Group
Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Epidemiology, Biostatistics and Prevention Institute (EBPI)
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:8 February 2018
Deposited On:04 Jan 2019 13:54
Last Modified:07 Jan 2019 09:50
Publisher:BioMed Central
ISSN:1471-2466
OA Status:Gold
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1186/s12890-018-0596-6
PubMed ID:19902981

Download

Download PDF  'Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol'.
Preview
Content: Published Version
Filetype: PDF
Size: 522kB
View at publisher
Licence: Creative Commons: Attribution 4.0 International (CC BY 4.0)