Condition category
Nervous System Diseases
Date applied
31/08/2015
Date assigned
07/09/2015
Last edited
03/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The spinal cord is a bundle of nerve fibres which is encased in a bony column (known as the spine). It is the most important link between the brain and the other nerves in the body (peripheral nervous system). Damage to the spinal cord (spinal cord injury, SCI) can lead to serious consequences. SCI can range from mild to severe, and can cause a partial or total loss of movement, often leaving people with life-long disability. People with a SCI are often not very active, as they are usually confined to a wheelchair. This study is part of a research programme to help encourage people with a long-term SCI to become more physically active. The programme works by giving people the tools, skills and support to have a healthy and active lifestyle, as well as helping them to cope better with day to day life. The aim of this study is to find out whether a programme such as this can help people suffering from a long-term SCI to become more active and become more independent.

Who can participate?
Adults who have been suffering from SCI for at least 10 years and are not very active.

What does the study involve?
Participants are randomly allocated into one of two groups. Participants in the first group (intervention group) are enrolled in a 16 week self-management course designed to help them lead a more active lifestyle. These courses consist of one home visit, five group meetings, and five individual sessions and each participant is given a personal counselor to help them through the process. Participants in the second group (control group) are given information about how to have an active lifestyle in the form of one meeting and an information booklet. Levels of physical activity are measured using questionnaires at the start of the study, at the end of the intervention period (week 16), and six months after the intervention (week 42).

What are the possible benefits and risks of participating?
Participating in this study is beneficial as having an active and healthy lifestyle is important good general health. The skills taught to participants will help them to maintain an active lifestyle long-term. There are not significant risks of participating, as all patients will still receive normal care. Participating will cost time and some physical effort for all patients in terms of the tests, questionnaires and keeping a diary.

Where is the study run from?
1. Rijndam Rehabilitation Centre (Netherlands)
2. De hoogstraat Rehabilitation Centre (Netherlands)
3. Roessingh Rehabilitation Centre (Netherlands)
4. Adelante Rehabilitation Centre (Netherlands)

When is the study starting and how long is it expected to run for?
January 2011 to December 2014

Who is funding the study?
1. Netherlands Organisation for Health Research and Development (Netherlands)
2. Fonds NutsOhra (Netherlands)

Who is the main contact?
1. Ms Hedwig Kooijmans (Scientific)
h.kooijmans@erasmusmc.nl
2. Dr Johannes Bussmann (Scientific)

Trial website

www.scionn.nl

Contact information

Type

Scientific

Primary contact

Ms Hedwig Kooijmans

ORCID ID

http://orcid.org/0000-0002-4474-5915

Contact details

Erasmus MC
Department of Rehabilitation Medicine
Rotterdam
3000CA
Netherlands
+31 10 7033906
h.kooijmans@erasmusmc.nl

Type

Scientific

Additional contact

Dr Johannes Bussmann

ORCID ID

Contact details

Erasmus MC
Department of Rehabilitation Medicine
Rotterdam
3000 CA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomized controlled trial of a self-management intervention aimed to increase an active lifestyle in persons with a long-term spinal cord injury: the HABITS (Healthy Active Behavioural IntervenTion in SCI) study

Acronym

HABITS

Study hypothesis

This intervention will show beneficial effects on:
1. A more active lifestyle
2. Self-management skills, such as proactive coping, problem-solving ability and self-efficacy
3. That participants with improvements in self-management skills will show more favourable effects on active healthy lifestyle than participants who do not improve in self-management skills.

Ethics approval

Erasmus MC Medical Ethics Committee, 14/10/2011, ref: MEC-2011-225

Study design

Double-blinded multi-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Spinal cord injury

Intervention

Study participants were randomized to a 16 week self-management intervention consisting of one home-visit, 5 group-meetings, 5 individual sessions and a personal counselor in order to improve self-management skills that would facilitate behavior change towards an active lifestyle, or to a control group that only received information about an active lifestyle by one meeting and a booklet.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Objectively measured physical activity, is assessed by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD), at baseline, 16 weeks and 42 weeks.
2. Subjectively measured physical activity is measured at baseline, 16 weeks and 42 weeks, by two accelerometer-based devices (ActiGraph GT3X+) [34]. One accelerometer attached at the wrist, the other to the spokes of one wheelchair wheel with special Velcro bands. Based on the results of the two accelerometers, a custom-made algorithm in MatLab differentiates between self-propelled wheelchair driving and other activities.

Secondary outcome measures

1. Self-management skills (self-efficacy, proactive coping) are measured at baseline, 16 weeks and 42 weeks with two scales:
1.1. The SCI exercise self-efficacy scale, measures self-reported self-efficacy for various types of physical exercise in individuals with SCI
1.2. The Utrecht Proactive Coping Competence scale , which assesses an individual’s experienced competency with regard to the various skills associated with proactive coping.
2. Stages of exercise change is measured at baseline, 16 weeks and 42 weeks using the Questionnaire University of Rhode Island continuous measure to assesses the six stages of change for regular exercise (based on the Trans-theoretical model)
3. Attitude, which is measured using the Exercise: Decisional Balance questionnaire at baseline, 16 weeks and 42 weeks. This questionnaire reflects the individual's relative weighing of the pros and cons of changing exercise behavior.

Overall trial start date

01/01/2011

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Spinal cord injury (for at least 10 years)
2. Aged between 28-65 years
3. PASIPD score (Physical activity scale for individuals with physical disabilities) lower than the 75th percentile of a Dutch SCI population
4. Ability to use a hand-rim wheelchair

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Progressive disease or severe co-morbidities
2. Psychiatric problems that would interfere with the study
3. Insufficient knowledge of the Dutch language to understand the purpose of the study and the testing methods
4. No intention to change exercise behaviour in the next 6 months

Recruitment start date

01/05/2012

Recruitment end date

01/06/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

Rijndam Rehabilitation Centre
Rotterdam
3015 LJ
Netherlands

Trial participating centre

De hoogstraat Rehabilitation Centre
Utrecht
3583 TM

Trial participating centre

Roessingh Rehabilitation Centre
Enschede
7500 AH

Trial participating centre

Adelante Rehabilitation Centre
Hoensbroek
6432 CC

Sponsor information

Organisation

Netherlands Organisation for Health Research and Development (ZonMW)

Sponsor details

Postbus 93 245
Den Haag
2509 AE
Netherlands

Sponsor type

Government

Website

Organisation

Fonds NutsOhra

Sponsor details

Postbus 229
Amsterdam
1000 AE
Netherlands

Sponsor type

Other

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Fonds NutsOhtra

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of this study will be presented in international scientific journals. Results will be orally presented at national and international congresses.

Intention to publish date

30/06/2016

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes