- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04031092
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Rissa, Norge
- Unicare Helsefort
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Bærbar teknologi uten tilbakemelding
Denne gruppen vil ha på seg det samme aktivitetsmåleapparatet som intervensjonsgruppen, men de vil ikke motta tilbakemelding om aktivitetsnivået sitt.
De vil ikke ha tilgang til mobilapplikasjonen.
De skal delta i samme rehabiliteringsprogram som tiltaksgruppen.
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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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Activity level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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oxygen uptake
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Lene Aasdahl, PhD MD, National Taiwan Normal University
- Studieleder: Jorunn Helbostad, Dr Philos, Norwegian University of Science and Technology
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019/800
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