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- Klinische proef NCT04031092
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Chronic pain is a vast problem with profound consequences for individuals and societies. Exercise and physical activity is an important part of the treatment for chronic pain. Use of wearable tech might be a way to help facilitate physical activity in patients with chronic pain. Here it will be evaluated whether use of wearable tech giving feedback about the user's activity level increases physical activity in patients participating in inpatient rehabilitation for chronic pain. The control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level.
The feedback application will give participants in the intervention group information about the number of PAI they earn each week. PAI is short for personal activity Intelligence. You earn PAI points every time your heart rate increases: The higher heart rate, the faster you earn PAI. Previous research have shown that those who achieve 100 PAI or more every week over time live for an average of more than eight years longer than others.
During the study all participants will take part in a traditional inpatient rehabilitation program. The program consist of two periods at the rehabilitation center with two weeks at home in-between. The study will take place during the two periods at the senter and the period at home. Time spent on physical activity and number of earned PAI's will be counted during the period at home.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Rissa, Noorwegen
- Unicare Helsefort
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for chronic pain.
Exclusion Criteria:
- not having a smartphone (will not be able to access the mobile application).
- using a wheelchair (the technology will be not able to measure activity correctly)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Draagbare technologie zonder feedback
Deze groep draagt dezelfde activiteitsmeter als de interventiegroep, maar krijgt geen feedback over hun activiteitenniveau.
Ze hebben geen toegang tot de mobiele applicatie.
Zij nemen deel aan hetzelfde revalidatieprogramma als de interventiegroep.
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traditional inpatient rehabilitation program.
An armwrist device measuring physical activity level, no reporting back to the user.
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Experimenteel: Wearable tech with feedback
This group will be wearing an activity measurement device (wristband) and receive feedback about their activity level through a mobile application while taking part in a traditional inpatient rehabilitation program for patients with chronic pain.
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An armwrist device measuring physical activity level.
The user will receive information about their physical activity level through their smartphone.
traditional inpatient rehabilitation program.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Activity level
Tijdsspanne: 2 weeks (time period at home between two stays at the rehabilitation center)
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Time spent in moderate to vigorous physical activity (minutes per day)
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2 weeks (time period at home between two stays at the rehabilitation center)
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Number of PAIs
Tijdsspanne: 2 weeks (time period at home between two stays at the rehabilitation center)
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mean number of Personal Activity Intelligence (PAI) points achieved per week
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2 weeks (time period at home between two stays at the rehabilitation center)
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Percentage achieving 100 PAIs per week
Tijdsspanne: 2 weeks (time period at home between two stays at the rehabilitation center)
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Personal Activity Intelligence (PAI)
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2 weeks (time period at home between two stays at the rehabilitation center)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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oxygen uptake
Tijdsspanne: 6 weeks (from inclusion to end of rehabilitation program)
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submaximal oxygen uptake measured by the Åstrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
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6 weeks (from inclusion to end of rehabilitation program)
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Anxiety and depression symptoms
Tijdsspanne: 6 weeks (from inclusion to end of rehabilitation program)
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HSCL-25 questionnaire
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6 weeks (from inclusion to end of rehabilitation program)
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Average pain
Tijdsspanne: 6 weeks (from inclusion to end of rehabilitation program)
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Visual Analogue Scale (VAS).
VAS is a straight horizontal line where the ends are defined as the extreme limits from the left (0-no pain) to the right (100-worst imaginable pain).
The patient is asked to mark his pain level on the line between the two endpoints.
The distance between 'no pain at all' and the mark then defines the subject's pain.
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6 weeks (from inclusion to end of rehabilitation program)
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Health related quality of life
Tijdsspanne: 6 weeks (from inclusion to end of rehabilitation program)
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EQ5D questionnaire
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6 weeks (from inclusion to end of rehabilitation program)
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Body weight
Tijdsspanne: 6 weeks (from inclusion to end of rehabilitation program)
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body weight in kilograms
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6 weeks (from inclusion to end of rehabilitation program)
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Body Mass Index score
Tijdsspanne: 6 weeks (from inclusion to end of rehabilitation program)
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weight in kilograms divided by height in metres squared
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6 weeks (from inclusion to end of rehabilitation program)
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Lene Aasdahl, PhD MD, National Taiwan Normal University
- Studie directeur: Jorunn Helbostad, Dr Philos, Norwegian University of Science and Technology
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2019/800
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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