A randomized controlled trial evaluating effects on health for individuals with mobility disability: eHealth vs. standard care
| ISRCTN | ISRCTN22387524 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22387524 |
| Secondary identifying numbers | 1 |
- Submission date
- 04/02/2018
- Registration date
- 03/04/2018
- Last edited
- 08/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
Solnavägen 1 E
Stockholm
113 65
Sweden
 ORCID ID |
0000-0003-0616-7779 |
|---|---|
| Phone | +46 (0)703 644 797 |
| daniel.berglind@ki.se |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Participant information material can be found at: https://www.twitchhealth.se/wp-content/uploads/Informationsbrev.-RCT-MD.-webb.pdf |
| Scientific title | An eHealth based health program vs. a standard care health program randomized controlled trial for individuals with mobility disability |
| Study objectives | 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(s) | Stockholm Ethical Review Board, 06/09/2017, ref: 2017/1206-31/1 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2017 |
| Completion date | 01/04/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 110 |
| Total final enrolment | 110 |
| Key inclusion criteria | 1. Classified with a mobility disability, acquired within the past three years 2. Aged 18-35 years |
| Key exclusion criteria | 1. Problems walking |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 01/04/2018 |
Locations
Countries of recruitment
- Sweden
Study participating centre
11323
Sweden
Sponsor information
University/education
Solnavägen 1E
Stockholm
113 65
Sweden
| Phone | +46 (0)8 524 800 00 |
|---|---|
| info@ki.se | |
| Website | www.ki.se |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Research council
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact peer reviewed journals. |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/04/2018 | Yes | No | |
| Results article | results | 04/02/2020 | 06/02/2020 | Yes | No |
| Results article | 03/02/2022 | 08/06/2023 | Yes | No | |
| Results article | Secondary analysis | 16/11/2020 | 08/06/2023 | Yes | No |
Editorial Notes
08/06/2023: Publication references added.
06/02/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
01/05/2018: Publication reference added.
