NCT04855461

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

April 19, 2021

Last Update Submit

May 28, 2021

Conditions

Keywords

Physical ActivityFear of MovementPatterns of activityPsychological status

Outcome Measures

Primary Outcomes (1)

  • International Physical Activity Questionnaire - Short Form

    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

Secondary Outcomes (5)

  • Demographics questionnaire

    Entire duration of study - 6 months

  • Brief Pain Inventory - Short Form

    Entire duration of study - 6 months

  • The Patterns of Activity Measure - Pain

    Entire duration of study - 6 months

  • The Tampa Scale of Kinesiophobia

    Entire duration of study - 6 months

  • The Depression, Anxiety and Stress Scale - 42

    Entire duration of study - 6 months

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with chronic pain

You may qualify if:

  • Individuals with pain lasting more than 12 weeks (chronic pain)
  • years or older

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Caledonian University

Glasgow, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chronic PainMotor ActivityKinesiophobia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Chee Wee Tan, PhD

    Glasgow Caledonian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chee Wee Tan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 22, 2021

Study Start

December 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations