- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05939531
Multi-domain Intervention Program for Post-stroke Bone Health in Older Adults (BOUNCE) (BOUNCE)
Development and Feasibility of a Multi-domain Intervention Program for Post-stroke Bone Health (BOUNCE - Bone Health in Older adUlts' iNtervention Post aCute strokE) in Hospital Pengajar Universiti Putra Malaysia (HPUPM)
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:
- What are the baseline sociodemographic and bone health characteristics of post-stroke older adults in this study?
- Is it feasible to undertake a larger RCT to assess the effectiveness and implementation of BOUNCE program?
- Is there a difference in bone loss between groups?
- Is there a difference in bone turnover markers at baseline and at six months?
- Is there a difference in the incidence of falls and fragility fractures between groups?
- How receptive are post-stroke patients/carers to the use of food/exercise diary?
- What are the perceived motivators and barriers to implementation of BOUNCE program within real clinical settings among healthcare professionals, participants and carers?
- What is the experience of healthcare professionals, participants and carers undergoing BOUNCE program?
Participants will be divided into two groups:
- Standard care
- Intervention group (BOUNCE Program) Researchers will compare both groups to see any changes in the bone mineral density and bone turnover markers before and after the intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hakimah Mohammad Sallehuddin, MBBS
- Phone Number: 2568 +60397692893
- Email: drhakimah@upm.edu.my
Study Locations
-
-
Selangor
-
Serdang, Selangor, Malaysia, 43400
- Recruiting
- Hospital Sultan Abdul Aziz Shah
-
Contact:
- Hakimah Mohammad Sallehuddin, MBBS
- Phone Number: 2568 +60397692893
- Email: drhakimah@upm.edu.my
-
Contact:
- Sazlina Shariff-Ghazali, PhD
- Email: sazlina@upm.edu.my
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 50 years old and older
- Neurologist diagnosed acute stroke within 90 days
- Has baseline biochemical test upon admission to the ward
- Able to undergo DXA scan
- Modified Rankin Score of 2 to 3
- Able to walk with or without aids
Exclusion Criteria:
- Known underlying malignancy
- Known major depression or severe psychological illness
- Known chronic kidney disease stage 3b (eGFR <45ml/min/1.73m2) or more
- Taken oral glucocorticoids therapy for at least three months
- Presence of cognitive impairment (ECAQ <7)
- Presence of coronary artery syndrome or congestive cardiac failure
- Presence of an uncontrolled respiratory condition
- Underlying malabsorption syndrome
- Underlying conditions other than stroke that impairs mobility (eg Severe Osteoarthritis, Parkinson's Disease, Multiple sclerosis)
- Known osteoporosis or fragility fracture
- Serum phosphate or calcium abnormalities
- Discharge to a nursing home or rehabilitation centre
- Already a participant in another trial/study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Care
Standard post-stroke care
|
Standard post-stroke care
|
Experimental: Intervention
BOUNCE Program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: At baseline and month-6
|
To examine the difference in Areal BMD change pre and post-intervention between groups
|
At baseline and month-6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment uptake
Time Frame: Throughout study period of average 1 year
|
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
Time Frame: At baseline and month-6
|
To examine the difference of BTM change pre and post-intervention between groups
|
At baseline and month-6
|
Retention
Time Frame: Assessment at month-4 and month-6
|
Number of participants followed-up among randomized
|
Assessment at month-4 and month-6
|
Treatment adherence
Time Frame: Assessment at month-4 and month-6
|
Number of participants who adhere to the nutritional and exercise interventions in each group
|
Assessment at month-4 and month-6
|
Acceptability
Time Frame: Assessment at month-4 and month-6
|
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
Time Frame: Assessment at month-4 and month-6
|
Qualitative study using a semi-structured interview on any side effects of the intervention
|
Assessment at month-4 and month-6
|
Falls
Time Frame: Assessment at month-4 and month-6
|
Number of participants experiencing falls during the study period as assessed by Falls Diary
|
Assessment at month-4 and month-6
|
Fracture
Time Frame: Assessment at month-4 and month-6
|
Number of participants experiencing bone fragility fracture during the study period as assessed by x-ray evidence
|
Assessment at month-4 and month-6
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Sazlina Shariff-Ghazali, PhD, Universiti Putra Malaysia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JKEUPM-2022-923
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Standard Care
-
Evandro Chagas Institute of Clinical ResearchAlejandro Marcel Hasslocher Moreno, MD MSc PhD student; Andrea Costa, MD PhD; Andrea Silvestre de Sousa, MD PhD and other collaboratorsUnknownChagas Heart DiseaseBrazil
-
Neuroscience Trials AustraliaNational Institute for Health Research, United Kingdom; Northern Ireland Chest... and other collaboratorsCompleted
-
University of OklahomaNational Cancer Institute (NCI)CompletedSmoking CessationUnited States
-
Avita MedicalNAMSACompletedVenous Leg UlcersUnited Kingdom, France
-
University of MichiganCompleted
-
University of OklahomaCompletedTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency ManagementUnited States
-
University of OklahomaEnrolling by invitationTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency Management | PregnancyUnited States
-
Institut de Cancérologie de LorraineTerminatedBreast CancerFrance
-
Indonesia UniversityCompletedCovid19 | AcupunctureIndonesia
-
Johns Hopkins UniversityRecruitingCompartment Syndrome of Leg | Extracorporeal Membrane Oxygenation Complication | Limb Ischemia, Critical | Limb IschemiaUnited States