- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04855461
Understanding the Determinants of Physical Activity Levels in Persons With Chronic Pain
28 maj 2021 uppdaterad av: Glasgow Caledonian University
The proposed research topic will investigate the determinants of physical activity (PA) levels in patients with chronic pain.
The aim of the research project is to quantify the self-reported and free-living physical activity levels in people with chronic pain.
Describe and explore the characteristics and relationships of these participants in terms of pain severity, fear of movement, patterns of activity, anxiety and depression, and number and differing types of long term conditions and how these all correlate with PA levels.
Explore PA levels of chronic pain patients and the correlation of psychosocial factors.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Observationell
Inskrivning (Förväntat)
100
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Chee Wee Tan, PhD
- Telefonnummer: +131 331 8038
- E-post: cheeweetan.uk@gcu.ac.uk
Studieorter
-
-
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Glasgow, Storbritannien
- Rekrytering
- Glasgow Caledonian University
-
Kontakt:
- Chee Wee Tan, PhD
- Telefonnummer: +131 331 8038
- E-post: cheeweetan.uk@gcu.ac.uk
-
Underutredare:
- Paul Cameron, PhD
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
People with chronic pain
Beskrivning
Inclusion Criteria:
- Individuals with pain lasting more than 12 weeks (chronic pain)
- 16 years or older
Exclusion Criteria:
- None
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
International Physical Activity Questionnaire - Short Form
Tidsram: Entire duration of study- 6 months
|
The International Physical Activity Questionnaire -Short Form measures free-living physical activity levels.
The questionnaire is psychometrically tested and used as an instrument to measure physical activity over the previous seven days of participants.
It was developed in 1998 to investigate physical activity levels based on the global standard.
The IPAQ short form has demonstrated to have acceptable measurement properties for use in a variety of settings.
The nine item instrument asks for time spent in walking, moderate and vigorous intensity physical activity of at least 10-minute durations.
|
Entire duration of study- 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Demographics questionnaire
Tidsram: Entire duration of study - 6 months
|
The demographics questionnaire will collect information about the participants' age, gender, nationality, ethnicity, duration of condition, living environment.
|
Entire duration of study - 6 months
|
Brief Pain Inventory - Short Form
Tidsram: Entire duration of study - 6 months
|
The Brief Pain Inventory - Short Form (BPI-SF) is a widely used questionnaire used with persons with chronic non-malignant painful conditions.
It is composed of a nine-item self-administered questionnaire to evaluate the severity of an individuals' pain and impact on their daily function.
The BPI-SF required participants to rate their current pain intensity, pain in the last 24 hours at its worst, least and average by using a numerical scale of 0-10.
Participants are also asked to rate the extent to which their pain interferes with seven quality of life domains.
The scales to these domains are bound by words "does not interfere" and "interferes completely".
The reliability has been reported in several chronic pain conditions.
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Entire duration of study - 6 months
|
The Patterns of Activity Measure - Pain
Tidsram: Entire duration of study - 6 months
|
The Patterns of Activity Measure -Pain (POAM-P) measures pacing/pattern of activity.
The questionnaire is composed of 30 self-reported items developed by Cane et al 2007 to measure three activity patterns; avoidance, overdoing and pacing in patients with chronic pain.
Each subscale consists of 10 items, where participants are given instructions such as: "People who have pain use different ways to do their daily activity.
This about how you do your daily activity".
Participants will then rate the statement as to the extent it applies to them on a five-point scale ranging from 0 (not at all) to 4 (always), each subscale ranges in score from 0-40.
The POAM-P scale for pacing has shown acceptable psychometric properties.
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Entire duration of study - 6 months
|
The Tampa Scale of Kinesiophobia
Tidsram: Entire duration of study - 6 months
|
The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-completed questionnaire that will be used to assess the subjective rating of kinesiophobia or fear of movement.
The TSK was originally developed to differentiate between non-excessive fear and phobia among patients with musculoskeletal pain.
It has been deemed a valid and reliable psychometric measure used for pain relating to different body parts.
The scores of the questionnaire ranged from 17 to 68 where higher scores indicate a higher degree of kinesiophobia.
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Entire duration of study - 6 months
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The Depression, Anxiety and Stress Scale - 42
Tidsram: Entire duration of study - 6 months
|
The Depression, Anxiety and Stress Scale - 42 (DASS-42) is a 42-item self-report instrument that consists of three scales that assess three negative emotional states of depression, anxiety and stress over the last week.
Each of the 42 items has four responses ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time).
The DASS42 requires participants to respond to statements immediately in relation to their feelings of the previous week.
Higher scores relate to higher levels of depression, anxiety or stress.
Previous findings showed that DASS42 has reliable psychometric properties in relation to internal consistency, convergent and discriminant validity in clinical and non-clinical populations.
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Entire duration of study - 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Chee Wee Tan, PhD, Glasgow Caledonian University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2020
Primärt slutförande (Förväntat)
30 juni 2021
Avslutad studie (Förväntat)
30 juni 2021
Studieregistreringsdatum
Först inskickad
19 april 2021
Först inskickad som uppfyllde QC-kriterierna
21 april 2021
Första postat (Faktisk)
22 april 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juni 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 maj 2021
Senast verifierad
1 maj 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EC1_CWT
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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