Clinical trial NCT05606510: The Effects of Mindful Exercise on Back Pain in Older Patients With Primary Osteoporosis
Official title: The Effects of Mindful Exercise on the Physical and Psychological Consequences of Older Priamry Osteoporotic Patients With Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Older People
Primary Osteoporosis
Back Pain
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 128
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of back pian level
timeFrame: 0,4,8,12,16 weeks post-intervention
measure: Change of balance ability
timeFrame: 0,4,8,12,16 weeks post-intervention
measure: Change of mindfulness level
timeFrame: 0,4,8,12,16 weeks post-intervention
measure: Change of kinesiophobia level
timeFrame: 0,4,8,12,16 weeks post-intervention
Secondary outcomes:
measure: Change of anxiety and depression level
timeFrame: 0,4,8,12,16 weeks post-intervention
Other outcomes:
Locations:
city: Kunming
country: China
facility: First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
state: Yunnan
Study officials:
affiliation: Yunnan University of Traditional Chinese Medicine
name: Fang Fei Lyu
role: PRINCIPAL_INVESTIGATOR
References: