Musculoskeletal PainNCT06848972
Development of Exercise Training Programme for Older People with Musculoskeletal Pain in the Community
A study testing Structured musculoskeletal exercise programme in people with Musculoskeletal Pain, run by International Islamic University Malaysia at 1 site in Malaysia.
Trial summary
The rate of musculoskeletal pain among older people is increasing worldwide and significantly impacts the quality of life. Regular exercise can help prevent and manage chronic musculoskeletal pain because older individuals who are not physically active may have less muscle strength and a higher risk of impairment and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Structured musculoskeletal exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2021to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adults aged 60 years old and above
- Lives in East Malaysia; Pahang, Kelantan, and Terengganu
- Have the mental capacity to give informed consent
- Had musculoskeletal pain
Who cannot join
- Had severely impaired hearing and sight that may have affected their ability to use the self-report scales
- Had neurological diseases or cognitive impairment
- Had a recent self-reported history of stroke or major surgery (in the past 6 months).
Trial locations and contacts
1 site in 1 country.
About this study
The rate of musculoskeletal pain among older people is increasing worldwide and significantly impacts the quality of life. Regular exercise can help prevent and manage chronic musculoskeletal pain because older individuals who are not physically active may have less muscle strength and a higher risk of impairment and injury than physically active persons. As a result, a tailored exercise program may prevent the loss of health-related quality of life among diverse elderly. This study aimed to develop a structured exercise module and identify its effect on musculoskeletal pain and the quality of life of older adults.
Read the detailed description
Background: The rate of musculoskeletal pain among older people is increasing worldwide and significantly impacts the quality of life. Regular exercise can help prevent and manage chronic musculoskeletal pain because older individuals who are not physically active may have less muscle strength and a higher risk of impairment and injury than physically active persons. As a result, a tailored exercise program may prevent the loss of health-related quality of life among diverse elderly.
Objectives: This study aimed to develop a structured exercise module and identify its effect on musculoskeletal pain and the quality of life of older adults.
Method: A quasi-experimental study was conducted among 60 older adults who experienced musculoskeletal pain in the East Coast Malaysia; Pahang, Terengganu, and Kelantan between January and February 2021. A set of questionnaires contained three parts; Part A: Socio-demographic Background, Part B: Musculoskeletal Pain (Pain Score), and Part C: Functional Limitation. Data was collected using a self-administered questionnaire through an online survey. Data collection processes go through three phases. Phase I: pre-intervention phase, Phase II: intervention session, and Phase III: post-intervention.
- Conditions
- Musculoskeletal Pain
- Being tested
- Structured musculoskeletal exercise programme
- Keywords
- older people, musculoskeletal pain, quality of life, Exercise training programme
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured musculoskeletal exercise programmeOther
The module emphasizes specific exercises, strength training with and without weight, flexibility exercises and balancing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | intervention session, the researcher conducted a structured musculoskeletal exercise programme in the intervention group, Receives: Other: Structured musculoskeletal exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal Pain (Pain Score)
It assess the severity of musculoskeletal pain in older people by using the Numerical Rating Scale (NRS). It ranged from 0 to 10; 0 indicates no pain, 5 for moderate pain, and 10 indicates the worst pain.
Measured: From enrollment to the end of treatment at 6 weeks
Functional Limitation
It focuses on the potential of participants to conduct daily life tasks through the use of the Malay edition of Lawton's Daily Living Instrumental Activities (Kadar et al., 2018; Morrow, 1999). This section includes 8 questions which were based on dichotomous questions (Yes or No). The total possible score is 8. This segment asks about the ability to use the telephone, shop, prepare food, do housekeeping, wash, mode of transport, be responsible of their medication, and their ability in managing their money.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jan 2021
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Islamic University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurin Syafiqah binti Mohd Jaias, International Islamic University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848972
- Sponsor's protocol ID
- IIUM/504/14/11/2 IREC2020-KON2
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available due to confidential issues
Publications
Morrow, S. (1999). Instrumental activities of daily living scale. American Journal of Nursing, 99(1), 24CC.
Kadar M, Ibrahim S, Razaob NA, Chai SC, Harun D. Validity and reliability of a Malay version of the Lawton instrumental activities of daily living scale among the Malay speaking elderly in Malaysia. Aust Occup Ther J. 2018 Feb;65(1):63-68. doi: 10.1111/1440-1630.12441. Epub 2018 Jan 9.
PubMed 29315609
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Exercise Training Programme for Older People with Musculoskeletal Pain in the Community
- ClinicalTrials.gov ID
- NCT06848972
- Acronym / sponsor ID
- IIUM/504/14/11/2 IREC2020-KON2
- Conditions
- Musculoskeletal Pain
- Keywords
- older people, musculoskeletal pain, quality of life, Exercise training programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- International Islamic University MalaysiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rate of musculoskeletal pain among older people is increasing worldwide and significantly impacts the quality of life. Regular exercise can help prevent and manage chronic musculoskeletal pain because older individuals who are not physically active may have less muscle strength and a higher risk of impairment and injury than physically active persons. As a result, a tailored exercise program may prevent the loss of health-related quality of life among diverse elderly. This study aimed to develop a structured exercise module and identify its effect on musculoskeletal pain and the quality of life of older adults.
Detailed description
Background: The rate of musculoskeletal pain among older people is increasing worldwide and significantly impacts the quality of life. Regular exercise can help prevent and manage chronic musculoskeletal pain because older individuals who are not physically active may have less muscle strength and a higher risk of impairment and injury than physically active persons. As a result, a tailored exercise program may prevent the loss of health-related quality of life among diverse elderly.
Objectives: This study aimed to develop a structured exercise module and identify its effect on musculoskeletal pain and the quality of life of older adults.
Method: A quasi-experimental study was conducted among 60 older adults who experienced musculoskeletal pain in the East Coast Malaysia; Pahang, Terengganu, and Kelantan between January and February 2021. A set of questionnaires contained three parts; Part A: Socio-demographic Background, Part B: Musculoskeletal Pain (Pain Score), and Part C: Functional Limitation. Data was collected using a self-administered questionnaire through an online survey. Data collection processes go through three phases. Phase I: pre-intervention phase, Phase II: intervention session, and Phase III: post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Structured musculoskeletal exercise programmeintervention session, the researcher conducted a structured musculoskeletal exercise programme in the intervention group, |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older adults aged 60 years old and above
- Lives in East Malaysia; Pahang, Kelantan, and Terengganu
- Have the mental capacity to give informed consent
- Had musculoskeletal pain
Key exclusion criteria (3 listed)
- Had severely impaired hearing and sight that may have affected their ability to use the self-report scales
- Had neurological diseases or cognitive impairment
- Had a recent self-reported history of stroke or major surgery (in the past 6 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured musculoskeletal exercise programmeThe module emphasizes specific exercises, strength training with and without weight, flexibility exercises and balancing exercises. | Other | Intervention |
Primary outcome
Musculoskeletal Pain (Pain Score)
Time frame: From enrollment to the end of treatment at 6 weeks
It assess the severity of musculoskeletal pain in older people by using the Numerical Rating Scale (NRS). It ranged from 0 to 10; 0 indicates no pain, 5 for moderate pain, and 10 indicates the worst pain.
Functional Limitation
Time frame: From enrollment to the end of treatment at 6 weeks
It focuses on the potential of participants to conduct daily life tasks through the use of the Malay edition of Lawton's Daily Living Instrumental Activities (Kadar et al., 2018; Morrow, 1999). This section includes 8 questions which were based on dichotomous questions (Yes or No). The total possible score is 8. This segment asks about the ability to use the telephone, shop, prepare food, do housekeeping, wash, mode of transport, be responsible of their medication, and their ability in managing their money.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- BackgroundMorrow, S. (1999). Instrumental activities of daily living scale. American Journal of Nursing, 99(1), 24CC.
- Background: PubMed 29315609Kadar M, Ibrahim S, Razaob NA, Chai SC, Harun D. Validity and reliability of a Malay version of the Lawton instrumental activities of daily living scale among the Malay speaking elderly in Malaysia. Aust Occup Ther J. 2018 Feb;65(1):63-68. doi: 10.1111/1440-1630.12441. Epub 2018 Jan 9.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available due to confidential issues
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured musculoskeletal exercise programme in people with Musculoskeletal Pain, run by International Islamic University Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal Pain (Pain Score) (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06848972, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.