NCT05234034

Brief Summary

chronic musculoskeletal disorders (CMDs) are a hugh burden to healthcare wordwide. Physical activity can improve outcomes related with CMDs, however dose response relationships are poorly understood. Therefore, to date it has not been possible to formulate general recommendations on optimal therapeutic quantity of physical activity. Furthermore, a complexity of possible facilitators and barriers has been stated to limit effective improvement of physical activity in therapy and currently applied low to moderate exercise intensities in rehabilitation could be below the required level to achieve optimal therapy outcomes. The primary objective of this study is to get insight on the impact of the intensity of the physical activity level on pain and disability in persons with CMDs. Second, the underlying facilitators and barriers to perform physical activity (at different intensities) during daily living will be evaluated. Third, the impact of the intensity of the physical activity level on the motivation to perform a rehabilitation program will be evaluated.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

January 17, 2022

Last Update Submit

February 15, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Global Physical Activity Questionnaire (GPAQ)

    GPAQ collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour and comprises of 16 questions (P1-P16). It allows categorization of the physical activity level of participants in either low, moderate, or vigorous. The domains are: Activity at work, Travel to and from places, and Recreational activities.

    at baseline (cross-sectional)

  • 5 multiple choice questions based on The International Fitness Scale (IFIS)

    This questioning evaluates 1) the perceived level of fitness of each participant in five subconstructs namely general physical fitness, cardiorespiratory fitness, muscular strength, speed/agility, and flexibility and 2) the perceived overall fitness level based on perceived physical ability in fictional daily situations.

    at baseline (cross-sectional)

Secondary Outcomes (7)

  • VAS-scores extracted from The Brief Pain Inventory short form (BPI-sf)(Q3-6)

    at baseline (cross-sectional)

  • Barriers to health quiz

    at baseline (cross-sectional)

  • Physical Activity and Leisure Motivation Scale (PALMS)

    at baseline (cross-sectional)

  • Depression Anxiety Stress Scale (DASS-21)

    at baseline (cross-sectional)

  • Fear-Avoidance Components Scale (FACS)

    at baseline (cross-sectional)

  • +2 more secondary outcomes

Other Outcomes (6)

  • Modified Oswestry Disability Index (MODI) (only persons with chronic low back pain)

    at baseline (cross-sectional)

  • Neck Disability Index (NDI) (only persons with chronic neck pain)

    at baseline (cross-sectional)

  • Shoulder Pain and Disability Index (SPADI) (only persons with chronic shoulder pain)

    at baseline (cross-sectional)

  • +3 more other outcomes

Study Arms (6)

chronic low back pain (LBP)

persons with chronic low back pain (LBP) will be included in this arm.

Other: online survey

chronic neck pain (CNP)

persons with chronic neck pain (CNP) will be included in this arm.

Other: online survey

chronic shoulder pain (CSP)

persons with chronic shoulder pain (CSP) will be included in this arm.

Other: online survey

osteoarthritis (OA)

persons with osteoarthritis (OA) will be included in this arm.

Other: online survey

fibromyalgia (FM)

persons with fibromyalgia (FM) will be included in this arm.

Other: online survey

chronic Temporomandibular Disorder (CTMD)

persons with chronic temporomandibular disorder (CTMD) will be included in this arm.

Other: online survey

Interventions

participantion consists of filling in an online survey that will take approximately 53 minutes. An adapted battery of questionnaires is provided for each subgroup.

chronic Temporomandibular Disorder (CTMD)chronic low back pain (LBP)chronic neck pain (CNP)chronic shoulder pain (CSP)fibromyalgia (FM)osteoarthritis (OA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons with one of the following musculoskeletal disorders: chronic low back pain (LBP); chronic neck pain (NP); chronic shoulder pain (CSP); osteoarthritis (OA); chronic Temporomandibular Disorder (CTMD); fibromyalgia (FM).

You may qualify if:

  • Age \>18 years
  • A medical diagnosis of one of the following musculoskeletal disorders: chronic low back pain (LBP); chronic neck pain (NP); chronic shoulder pain (CSP); osteoarthritis (OA); chronic Temporomandibular Disorder (CTMD); fibromyalgia (FM).
  • Chronic pain, defined as: pain that persists or recurs for longer than three months (fluctuations in the severity of the pain during this period are allowed)
  • Ability to read and understand the English or Dutch language.

You may not qualify if:

  • Surgery or invasive procedures within the last 3 months that can impact the physical activity level.
  • Comorbidities: paresis and sensory disturbances with a neurological cause in the lower extremities, diabetes mellitus, autoimmune disorders, and all other non-musculoskeletal disorders that can produce pain and affect the physical activity level or physical functioning.
  • Pregnancy or trying to get pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, België, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Annick Timmermans

    Hasselt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marleen Missotten

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2022

First Posted

February 10, 2022

Study Start

February 15, 2022

Primary Completion

July 1, 2023

Study Completion

January 1, 2024

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations