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| Name | Class |
|---|---|
| Ministry of Higher Education, Malaysia | OTHER |
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The goal of this feasibility randomized controlled trial is to assess the feasibility and compare the changes in bone mineral density before and after the intervention in post-stroke older adults. The main question[s] it aims to answer are:
Participants will be divided into two groups:
Stroke causes secondary osteoporosis, falls and fractures. The 2020 Malaysian Stroke Guideline recommends fall and fracture risk assessment in all older stroke patients, but it does not make a firm recommendation on the interventions to address post-stroke bone loss. Stroke increased the risk of fall by 1.5 times compared to the normal population and quadrupled the risk of fracture. Hip fractures will increase the cost for treatment, hospitalization, operation and complicate the rehabilitation process from the stroke itself.
Hence, our study aims to develop and assess the feasibility of a multi-domain intervention (BOUNCE program) for bone health among older adults with acute stroke. A multi-domain non-pharmacological intervention is proposed due to the complex nature of bone loss in older post-stroke patients such as low serum Vitamin D, sarcopenia, frailty, comorbidity, ageing and hemiparesis. Therefore, this study is designed through the 2021 MRC Framework of Developing and Evaluating Complex Intervention and is divided into 3 phases. The first phase is a systematic review to identify evidence on non-pharmacological interventions for post-stroke bone health. Phase 2 is the development and validation of a novel multi-domain intervention protocol for BOUNCE program through an expert consensus development conference. The final phase will be a feasibility trial of BOUNCE program, which is further divided into two components. The first component is a randomized, controlled, single-blinded feasibility trial (RCT) of 6-months intervention (BOUNCE program) versus standard care, which primarily assesses bone loss through bone mineral density and bone turnover markers. The second component is a qualitative analysis through Focused Group Discussions on the feasibility of BOUNCE program among healthcare professionals, patients and carers. The outcome of this study will inform the next step of evaluation, which is a future full RCT to assess the effectiveness and economic studies before it can be implemented widely.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | Standard post-stroke care |
|
| Intervention | Experimental | BOUNCE Program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOUNCE Program | Behavioral | Intervention arm: Bone-building exercises will be incorporated into the standard post-stroke exercises, as well as Nutritional intervention consisting of individualized diet plan based on calorie requirement, high-quality protein intake, vitamin D, Calcium and micronutrients with a one-to-one virtual session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Areal Bone Mineral Density (BMD) at the Neck of Femur as measured by Hologic Dual X-ray Absorptiometry in g/cm2 | To examine the difference in Areal BMD change pre and post-intervention between groups | At baseline and month-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment uptake | Number of participants randomized among screened | Throughout study period of average 1 year |
| Change in the level Bone Turnover Markers (BTM) as assessed by C-Telopeptide-Cross-Linked Type I Collagen (CTx) in ng/ml and Procollagen Type I N-Terminal Propeptide (PINP) in ng/ml |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hakimah Mohammad Sallehuddin, MBBS | Contact | +60397692893 | 2568 | drhakimah@upm.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Sazlina Shariff-Ghazali, PhD | Universiti Putra Malaysia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultan Abdul Aziz Shah | Recruiting | Serdang | Selangor | 43400 | Malaysia |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard Care | Behavioral | Standard post-stroke care |
|
To examine the difference of BTM change pre and post-intervention between groups |
| At baseline and month-6 |
| Retention | Number of participants followed-up among randomized | Assessment at month-4 and month-6 |
| Treatment adherence | Number of participants who adhere to the nutritional and exercise interventions in each group | Assessment at month-4 and month-6 |
| Acceptability | Qualitative study using semi-structured interviews (3 Focus group discussions consist of 10 participants, 10 healthcare professionals and 10 carers) on the motivators, barriers and experience of the intervention | Assessment at month-4 and month-6 |
| Side-effects | Qualitative study using a semi-structured interview on any side effects of the intervention | Assessment at month-4 and month-6 |
| Falls | Number of participants experiencing falls during the study period as assessed by Falls Diary | Assessment at month-4 and month-6 |
| Fracture | Number of participants experiencing bone fragility fracture during the study period as assessed by x-ray evidence | Assessment at month-4 and month-6 |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |