Condition category
Signs and Symptoms
Date applied
04/02/2018
Date assigned
03/04/2018
Last edited
01/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Young adults with mobility disability (MD) are less likely to take part in regular physical activity (PA) compared with their able-bodied peers, and inactive adults with MD are 50% more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions, little attention has been on interventions aiming to increase PA among individuals with MD. This study aims to evaluate the effect of an eHealth programme compared to standard care lifestyle exercise programme.

Who can participate?
Adults aged 18-35 with mobility disability

What does the study involve?
Participants are randomly allocated into one of two groups. Those in the first group receive a 12 week eHealth walking and exercise programme delivered via smartphone apps. The other group receive standard care individualized lifestyle exercise and dietary programme, lead by healthy educators and personal trainers in face to face weekly sessions. Participants have outcomes measured before the programme, at programme midpoint (6 weeks), end point (12 weeks) and one year after completion.

What are the possible benefits and risks of participating?
Participants may benefit from health improvements from increased physical activity. Participation is associated with low risk from low intensity physical activity and VO2max testing. Blood samples are taken by a nurse.

Where is the study run from?
TWITCH Healthcare AB (Sweden)

When is the study starting and how long is it expected to run for?
August 2017 to April 2019

Who is funding the study?
Swedish Research Council for Health, Working life and Welfare (FORTE) (Sweden)

Who is the main contact?
Dr Daniel Berglind (scientific)
daniel.berglind@ki.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Berglind

ORCID ID

http://orcid.org/0000-0003-0616-7779

Contact details

Solnavägen 1 E
Stockholm
113 65
Sweden
+46 (0)703 644 797
daniel.berglind@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

An eHealth based health program vs. a standard care health program randomized controlled trial for individuals with mobility disability

Acronym

Study hypothesis

An eHealth based exercise program entails similar increases in moderate to vigorous physical activity, at 12 weeks and at 12 months’ follow-up, compared with a standard care supervised lifestyle exercise programme.

Ethics approval

Stockholm Ethical Review Board, 06/09/2017, ref: 2017/1206-31/1

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Participant information material can be found at: https://www.twitchhealth.se/wp-content/uploads/Informationsbrev.-RCT-MD.-webb.pdf

Condition

Self-reported mobility disability

Intervention

A block randomized control design allocates the sample of young adults with MD into two equal groups. Those in the eHealth group have a low-cost 12 week walking and exercise programme delivered via smartphone apps (a walking app, an exercise app and a food photography app). These also provide training/health advice and feedback. The other group receive a 12 week standard care individualised lifestyle exercise and dietary programme delivered by health educators and personal trainers. This includes face to face counselling and weekly personal trainer led sessions.

The 12 weeks’ trial will examine the efficacy of an eHealth vs. a standard care exercise program on PA level (primary outcome) and as secondary outcomes effects on health related quality of life, musculoskeletal pain, perceived stress, symptoms of depression, eating behavior, workability, body composition and fitness. Examinations will be performed at baseline, midpoint (week 6), at the end of the intervention (week 12) and 12 months’ post intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Levels of moderate to vigorous physical activity (MVPA) measured by the Actigraph GT3X+ accelerometer at baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention

Secondary outcome measures

1. Health related quality of life is measured by SF-36 at baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention
2. Musculoskeletal pain is measured by visual analogue scale (VAS) at baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention
3. Perceived stress is measured by the perceived stress scale at baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention
4. Symptoms of depression is measured by the Beck Depression Inventory-II baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention
5. Eating behavior is measured by a 24 hour recall questionnaire at baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention
6. Workability is measured by the symptom of depression questionnaire (SDQ) at baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention
7. Body composition is measured by bioelectrical impedence (BIA), weight, height, and waist circumference measures at baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention
8. Fitness is measured by the Elin-Ekbom-Bak submaximal VO2max test at baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention
9. Blood samples will be taken for genetic/epigenetic analysis at baseline, 6 weeks (midpoint of intervention), 12 weeks (endpoint of intervention) and 12 months post intervention.

Overall trial start date

01/08/2017

Overall trial end date

01/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Classified with a mobility disability, acquired within the past three years
2. Aged 18-35 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Problems walking

Recruitment start date

01/03/2018

Recruitment end date

01/04/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

TWITCH Healthcare AB
Stockholm
11323
Sweden

Sponsor information

Organisation

Karolinska Institute

Sponsor details

Solnavägen 1E
Stockholm
113 65
Sweden
+46 (0)8 524 800 00
info@ki.se

Sponsor type

University/education

Website

www.ki.se

Funders

Funder type

Research council

Funder name

Swedish Research Council for Health, Working Life and Welfare, FORTE (Forskningsrådet om Hälsa, Arbetsliv och Välfärd)

Alternative name(s)

Swedish Research Council for Health, Working Life and Welfare, FORTE

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Results and Publications

Publication and dissemination plan

Planned publication in high-impact peer reviewed journals.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Daniel Berglind, daniel.berglind@ki.se

Intention to publish date

01/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29703242

Publication citations

Additional files

Editorial Notes

01/05/2018: Publication reference added.