A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial

January 4, 2021 updated by: TSE Mun Yee Mimi, The Hong Kong Polytechnic University

Background: The high prevalence of chronic pain in community-dwelling older adults requires attention from nurses. The aim of the present study is to use a music-with-movement exercise program to improve the pain situations of older adults with chronic pain.

Aims and objectives:

The aim of this study is to implement a music-with-movement exercise program (MMEP) for older adults suffering from chronic pain.

The objectives of this study are:

  • To evaluate the effects of a music-with-movement exercise program on improving the pain intensity, pain self-efficacy, mood, and quality of life of the older adults with chronic pain
  • To observe the participants' level of adherence to the music-with-movement exercise by using an exercise logbook and measurements of heart rate

Anticipated outcomes: This study will be a pilot randomized controlled trial. An 8-week music-with-movement exercise program will be used as the intervention for older adults with chronic pain in District Elderly Centers in Hong Kong. It will consist of four sessions of center-based, face-to-face activities and four weeks home-based and digital-based activities delivered through a WhatsApp group. A music therapist, in consultation with the physiotherapist, will lead the center-based activities. Each center-based session will consist of 30 minutes of music-with-movement exercise and 10 minutes of instruction on pain knowledge and pain management. Each participant will receive an exercise logbook to practice and record the frequency of their engagement in the music-with-movement exercise at home. They will receive WhatsApp reminders to remind them to continue the home-based sessions. Outcome measures include pain intensity, pain self-efficacy, mood, heart rate and physical activity intensity, and quality of life. Data will be collected before and after the intervention. Participants need to complete the exercise logbook to record their adherence to the intervention. The findings of this study will provide clinical implications for nurses to integrate music with movement exercise to manage pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 60 or above
  • Can understand Cantonese
  • Have a history of non-cancer pain in the past 3 months
  • Have a pain score of at least 2 as measured by the Numeric Rating Scale (on an 11-point numeric scale)
  • Able to take part in an exercise and stretching program
  • Owns a smartphone and can access the Internet

Exclusion Criteria:

  • Have severe visual and/or auditory deficits
  • Have a serious organic disease or malignant tumor
  • Have a mental disorder diagnosed by neurologists or psychiatrists
  • Had surgical treatments in the past two months
  • Experienced drug addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
The music-with-movement exercise program (MMEP) is an 8-week program. In the first 4 weeks a center-based program will be offered in the District Elderly Centers, and from week 1 to week 8 home-based and digital-based activities will be delivered via a WhatsApp group.
Other: Music-with-movement exercise
A music-with-movement exercise programme to reduce chronic pain in older adults.
No Intervention: Control group
The participants in the control group will continue to receive their usual care and receive a one-page pain management pamphlet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Baseline, Week 8
Changes from baseline to Week 8 in pain intensity using the Chinese version of Brief Pain Inventory (BPI-C)
Baseline, Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain self-efficacy
Time Frame: Baseline, Week 8
Changes from baseline to Week 8 in pain self-efficacy using the Chinese version of Pain Self-efficacy Questionnaire
Baseline, Week 8
Loneliness
Time Frame: Baseline, Week 8
Changes from baseline to Week 8 in loneliness using the Chinese version of De Jong Gierveld Loneliness Scale
Baseline, Week 8
Depression
Time Frame: Baseline, Week 8
Changes from baseline to Week 8 in depression using the Chinese version of Geriatric Depression Scale
Baseline, Week 8
Satisfaction and acceptability
Time Frame: Week 8
Questions designed by the research team to collect the participants' satisfaction and acceptability
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mimi MY Tse, PhD, School of Nursing, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MMEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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