Wearable Device to Increase Physical Activity Amongst Adults With Pain

NCT ID: NCT05860478

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-06

Study Completion Date

2024-04-30

Brief Summary

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This protocol is for a pragmatic mixed methods randomized parallel-group exploratory feasibility trial to examine all facets of a proposed future phase III trial on the use of wearable device to increase physical activity and possibly reduce pain amongst middle-aged people with musculoskeletal (MSK) chronic pain. The feasibility study is intended to answer the following research questions:

Question 1 Evaluate the acceptability of all aspect of the study design of wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain.

Question 2: Is it feasible and acceptable to use wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain? Question 3: How can using wearable device promote physical activity effectively in middle-aged adults with musculoskeletal chronic pain?

Participants will be recruited from a National Health Service (NHS) pain clinic and randomised on a ratio1:3 into control group (standard care) and intervention group (standard care combined with wearable device). The feasibility study will last for 18 months, participants involvement will be for 24 weeks. Patients in both groups can participate in any physical activity, including planned, structured, and repetitive bodily movement exercise or occupational and recreational PA. Qualitative semi-structured interview will be conducted at baseline and week-12, while outcome measures will be conducted at baseline, 4-week, 8-week,12-week, and 24-week for all participants to examine their pain, physical activity, and their responses to the trial. Qualitative interview will be conducted for stakeholders which include clinicians and service managers after all patient data has been collected. This study has the potential to make an original contribution to provide key data on the feasibility, acceptability, and effectiveness of using wearable technology to support physical activity intervention for middle-aged adults with musculoskeletal chromic pain.

Detailed Description

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Conditions

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Musculoskeletal Chronic Pain Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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wearable device plus standard care

Group Type EXPERIMENTAL

Wearable device

Intervention Type DEVICE

The wearable device includes a motion sensor, and is worn around the wrist, and the device records a participant's physical activity .

standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wearable device

The wearable device includes a motion sensor, and is worn around the wrist, and the device records a participant's physical activity .

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient of any gender identity 40-65 years old.
* Willingness to participate in the trial.
* Able to understand and speak sufficient English to engage during interviews.
* They have self-reported persistent or recurrent musculoskeletal pain for three months or longer.
* Participants will be receiving treatment for musculoskeletal chronic pain.

Exclusion Criteria

* Palliative patient.
* Patients of any gender identity younger than 40-year-old or older than 65-year-old.
* Patients that are dependent on alcohol or drugs.
* Involvement with other ongoing studies.
* Patients unable to complete the questionnaires as judged by the researcher.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal London Hospital for Integrated Medicine

OTHER

Sponsor Role collaborator

University of West London

OTHER

Sponsor Role lead

Responsible Party

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John Hughes

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Royal London Hospital for Integrated Medicine, UCLH NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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John Hughes

Role: CONTACT

02034488883

Facility Contacts

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John Hughes

Role: primary

02034488883

Other Identifiers

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314666

Identifier Type: -

Identifier Source: org_study_id

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