Older PeopleNCT05606510
The Effects of Mindful Exercise on Back Pain in Older Patients With Primary Osteoporosis
A study testing Mindful exercise in people with Older People and Primary Osteoporosis, run by University of Malaya at 1 site in China.
Trial summary
The goal of this randomized control trial is to determine the effects of a mindful exercise program on physical (back pain and balance) and psychological (mindfulness, kinesiophobia, anxiety and depression) consequences of primary osteoporosis in older patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Older People, Primary Osteoporosis, Back Pain
- What is being tested?
- Mindful exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2023to 30 Apr 2024
- 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
- Aged 60 years and above, and can use smart phone.
- Patients diagnosed as primary osteoporosis with mild to moderate back pain [Numeric Rating Scale (NRS) score 1-6] for more than 3 months.
- Patients with low risk of falls that measured by the Morse Fall Risk Scale (MFS) [MFS score <25].
- Patients with no visual, hearing, mental problems or cognitive impairment [assessed using Short Portable Mental Status Questionnaire] that could prevent communication.
- Patients with no secondary diseases resulting in decreased mobility, functional status.
- Patients with no neurological or muscle diseases, ability to continuously attend the exercise program.
Who cannot join
- Patients with secondary osteoporosis or other diseases that can interfere with bone metabolism.
- Patients taking of concomitant medication that affected calcium and bone metabolism.
- Patients who presence of medical conditions that could have interfered with the outcomes of the trial.
- Patients with cardiovascular or cerebrovascular disease (blood pressure higher than 160/110 mmHg on medication, with systolic blood pressure less than 90 mmHg, with heart stents or body implantation, with a history of thrombosis within the past 6 months).
- Patients who are in the rehabilitation period for surgical intervention.
- Patients who have not recovered from muscle strain, joint injuries or fractures (fractures within the past three months).
- Patients undergoing other psychotherapy, including taking psychotropic medications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Kunming, Yunnan, 650021
Jun Ma, +86 0871-63635609, ynszyyylunli@126.com
Fang Fei Lyu
About this study
Official title: The Effects of Mindful Exercise on the Physical and Psychological Consequences of Older Priamry Osteoporotic Patients With Back Pain
The goal of this randomized control trial is to determine the effects of a mindful exercise program on physical (back pain and balance) and psychological (mindfulness, kinesiophobia, anxiety and depression) consequences of primary osteoporosis in older patients. The main questions it aims to answer are:
- What are the levels of pain, balance, mindfulness, kinesiophobia, anxiety and depression in older patients with primary osteoporosis?
- Are there differences in pain, balance, mindfulness, kinesiophobia, anxiety and depression according to sociodemographic-clinical characteristics of the patients?
- Are there differences in pain, balance, mindfulness, kinesiophobia, anxiety and depression between the intervention (mindful exercise) and control (usual care) groups of older patients with primary osteoporosis? 128 participants who meet the criteria will be recruited from the pain department of a Tertiary A level provincial Traditional Chinese Medicine hospital in Mainland China, and randomly assigned to the intervention group or control group. All patients in both groups will receive usual care, including routine medicine and nursing care. The study will last for 12 weeks (one-week training in hospital and 11-week on-line sessions at home) and 4-week follow up.
Read more
Patients in the intervention group will receive a group-based mindful exercise which will be conducted 5 times per week, 30 minutes per session, and co-led by a mindfulness-trained main researcher and a professional exercise specialist for the first week (week 1) hospitalization. When they discharge, on-line sessions (week 2-12) will be conducted by the main researcher from Monday to Friday. Patients and primary caregivers will be taught how to use 'Tencent meet' software. Upon discharge, a WeChat group will be set up to notify the exercise time and send the links for the online sessions. Those in the control group will received routine medicine and nursing care as usual, and only be taught on the hospital-recommended movements (physical stretching) and encouraged to do it at home on their own. All the variables (pain, mindfulness, kinesiophobia, anxiety and depression) and the TUG test (balance) will be measured at the following time point: baseline (Time 1), week 4 (Time 2), week 8 (Time 3), week 12 (Time 4, immediately post-intervention) and week 16 (Time 5, 4 weeks after the intervention) for the two groups of patients.
The study will obtain ethical clearance from the study setting, as well as written consent from the participants. Descriptive statistics will be computed for all variables. Normality and homogeneity of the variances will be tested using the Shapiro-Wilk and Levene tests, respectively. The data will be analyzed using mixed-model analysis of variance to test the main and interaction effects of group (independent factor) and time (repeated-measures factor) on the dependent variables. The findings of the study would certainly have implications for the treatment of older patients with primary osteoporosis, especially non-pharmacological treatment.
- Conditions
- Older People, Primary Osteoporosis, Back Pain
- Being tested
- Mindful exercise, usual care
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful exerciseOther
In this study, a modified mindful exercise (ME) program based on mindful standing yoga refers to a type of exercise that aims to harmonize the body and mind through the effect of mindfulness meditation and stretching-awareness to carry on the actual moment through body movement and surroundings without any judgement.
usual careOther
Routine medicine and nursing care; as well as hospital-recommended movements (physical stretching).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A 12-week, group-based mindful exercise program which will be conducted 5 times per week, 30 minutes per session. Receives: Other: Mindful exercise |
| Control | Other | Routine medicine, nursing care, and hospital-recommended exercise. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of back pian level
Back pain will be measured using the Chinese version of Global Pain Scale (GPS), which has 20 items with four dimensions: pain, feelings, clinical outcomes, activities. Each item is rate with 11-point scale ranging from 0-10. The total score is 0 to 200 points and the higher the score, the higher the pain intensity and interference.
Measured: 0,4,8,12,16 weeks post-intervention
Change of balance ability
Balance will be measured by the Timed Up and Go (TUG) test using the following equipment: stopwatch, standard chair (chair with about 46 cm high and the armrest about 20 cm high), the measured distance of 3 meters (Zakaria et al., 2015). There is no official cut-off for TUG, but previous study implied that a score of >12 seconds indicates a high risk of falling.
Measured: 0,4,8,12,16 weeks post-intervention
Change of mindfulness level
Mindfulness will be measured using the Chinese version the short form of the Five Facet Mindfulness Questionnaire (FFMQ-SF), which consists 20 items with five dimensions: Observing; Describing; Acting with-awareness; Nonjudging to inner experience; Nonreacting to inner experience. Each item is scored on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true) with a total score of 20 to 100. The higher scores indicating a high level of mindfulness.
Measured: 0,4,8,12,16 weeks post-intervention
Change of kinesiophobia level
Kinesiophobia will be measured using the Chinese version of the Tampa Scale of Kinesiophobia-11 (TSK-11) which contains 11 items with three dimensions: Somatic focus (6 items), Activity avoidance (3 items), and Avoidance beliefs (2 items). Each item was rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). A total score ranging from 11 to 44. The higher scores correspond to a greater perceived level of kinesiophobia.
Measured: 0,4,8,12,16 weeks post-intervention
Secondary outcomes (1)
Change of anxiety and depression level
Anxiety and Depression will be measure using the Chinese version of Hospital Anxiety and Depression Scale (HADS) which has 14 items with 2 subscales of anxiety and depression. Each item is scored on 0 to 3. According to the standards of the original authors, a total score of 0 to 7 represents no anxiety or depression, 8 to 10 refers to possibly or borderline anxiety or depressiom, and 11 to 21 represents possible significant anxiety or depression.
Measured: 0,4,8,12,16 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start16 Feb 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Fei Lyu, Principal investigator, Yunnan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606510
- Sponsor's protocol ID
- XW[2022]
- Status last verified
- May 2023
- First submitted
- 21 Oct 2022
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindful Exercise on the Physical and Psychological Consequences of Older Priamry Osteoporotic Patients With Back Pain
- ClinicalTrials.gov ID
- NCT05606510
- Acronym / sponsor ID
- XW[2022]
- Conditions
- Older People, Primary Osteoporosis, Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 4 Nov 2022 (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 goal of this randomized control trial is to determine the effects of a mindful exercise program on physical (back pain and balance) and psychological (mindfulness, kinesiophobia, anxiety and depression) consequences of primary osteoporosis in older patients. The main questions it aims to answer are:
- What are the levels of pain, balance, mindfulness, kinesiophobia, anxiety and depression in older patients with primary osteoporosis?
- Are there differences in pain, balance, mindfulness, kinesiophobia, anxiety and depression according to sociodemographic-clinical characteristics of the patients?
- Are there differences in pain, balance, mindfulness, kinesiophobia, anxiety and depression between the intervention (mindful exercise) and control (usual care) groups of older patients with primary osteoporosis? 128 participants who meet the criteria will be recruited from the pain department of a Tertiary A level provincial Traditional Chinese Medicine hospital in Mainland China, and randomly assigned to the intervention group or control group. All patients in both groups will receive usual care, including routine medicine and nursing care. The study will last for 12 weeks (one-week training in hospital and 11-week on-line sessions at home) and 4-week follow up.
Patients in the intervention group will receive a group-based mindful exercise which will be conducted 5 times per week, 30 minutes per session, and co-led by a mindfulness-trained main researcher and a professional exercise specialist for the first week (week 1) hospitalization. When they discharge, on-line sessions (week 2-12) will be conducted by the main researcher from Monday to Friday. Patients and primary caregivers will be taught how to use 'Tencent meet' software. Upon discharge, a WeChat group will be set up to notify the exercise time and send the links for the online sessions. Those in the control group will received routine medicine and nursing care as usual, and only be taught on the hospital-recommended movements (physical stretching) and encouraged to do it at home on their own. All the variables (pain, mindfulness, kinesiophobia, anxiety and depression) and the TUG test (balance) will be measured at the following time point: baseline (Time 1), week 4 (Time 2), week 8 (Time 3), week 12 (Time 4, immediately post-intervention) and week 16 (Time 5, 4 weeks after the intervention) for the two groups of patients.
The study will obtain ethical clearance from the study setting, as well as written consent from the participants. Descriptive statistics will be computed for all variables. Normality and homogeneity of the variances will be tested using the Shapiro-Wilk and Levene tests, respectively. The data will be analyzed using mixed-model analysis of variance to test the main and interaction effects of group (independent factor) and time (repeated-measures factor) on the dependent variables. The findings of the study would certainly have implications for the treatment of older patients with primary osteoporosis, especially non-pharmacological treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Mindful exerciseA 12-week, group-based mindful exercise program which will be conducted 5 times per week, 30 minutes per session. |
| Control | Other | Other: usual careRoutine medicine, nursing care, and hospital-recommended exercise. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 60 years and above, and can use smart phone.
- Patients diagnosed as primary osteoporosis with mild to moderate back pain [Numeric Rating Scale (NRS) score 1-6] for more than 3 months.
- Patients with low risk of falls that measured by the Morse Fall Risk Scale (MFS) [MFS score <25].
- Patients with no visual, hearing, mental problems or cognitive impairment [assessed using Short Portable Mental Status Questionnaire] that could prevent communication.
- Patients with no secondary diseases resulting in decreased mobility, functional status.
Key exclusion criteria (7 listed)
- Patients with secondary osteoporosis or other diseases that can interfere with bone metabolism.
- Patients taking of concomitant medication that affected calcium and bone metabolism.
- Patients who presence of medical conditions that could have interfered with the outcomes of the trial.
- Patients with cardiovascular or cerebrovascular disease (blood pressure higher than 160/110 mmHg on medication, with systolic blood pressure less than 90 mmHg, with heart stents or body implantation, with a history of thrombosis within the past 6 months).
- Patients who are in the rehabilitation period for surgical intervention.
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 |
|---|---|---|
| Mindful exerciseIn this study, a modified mindful exercise (ME) program based on mindful standing yoga refers to a type of exercise that aims to harmonize the body and mind through the effect of mindfulness meditation and stretching-awareness to carry on the actual moment through body movement and surroundings without any judgement. | Other | Intervention |
| usual careRoutine medicine and nursing care; as well as hospital-recommended movements (physical stretching). | Other | Control |
Primary outcome
Change of back pian level
Time frame: 0,4,8,12,16 weeks post-intervention
Back pain will be measured using the Chinese version of Global Pain Scale (GPS), which has 20 items with four dimensions: pain, feelings, clinical outcomes, activities. Each item is rate with 11-point scale ranging from 0-10. The total score is 0 to 200 points and the higher the score, the higher the pain intensity and interference.
Change of balance ability
Time frame: 0,4,8,12,16 weeks post-intervention
Balance will be measured by the Timed Up and Go (TUG) test using the following equipment: stopwatch, standard chair (chair with about 46 cm high and the armrest about 20 cm high), the measured distance of 3 meters (Zakaria et al., 2015). There is no official cut-off for TUG, but previous study implied that a score of >12 seconds indicates a high risk of falling.
Change of mindfulness level
Time frame: 0,4,8,12,16 weeks post-intervention
Mindfulness will be measured using the Chinese version the short form of the Five Facet Mindfulness Questionnaire (FFMQ-SF), which consists 20 items with five dimensions: Observing; Describing; Acting with-awareness; Nonjudging to inner experience; Nonreacting to inner experience. Each item is scored on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true) with a total score of 20 to 100. The higher scores indicating a high level of mindfulness.
Change of kinesiophobia level
Time frame: 0,4,8,12,16 weeks post-intervention
Kinesiophobia will be measured using the Chinese version of the Tampa Scale of Kinesiophobia-11 (TSK-11) which contains 11 items with three dimensions: Somatic focus (6 items), Activity avoidance (3 items), and Avoidance beliefs (2 items). Each item was rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). A total score ranging from 11 to 44. The higher scores correspond to a greater perceived level of kinesiophobia.
1 secondary outcome
Change of anxiety and depression level
Time frame: 0,4,8,12,16 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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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.
Fang Fei Lyu principal investigator
Yunnan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful exercise in people with Older People and Primary Osteoporosis, run by University of Malaya at 1 site in China.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Ma (+86 0871-63635609, ynszyyylunli@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of back pian level (time frame: 0,4,8,12,16 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.