Multi-domain Intervention Program for Post-stroke Bone Health in Older Adults (BOUNCE)
NCT ID: NCT05939531
Last Updated: 2024-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
70 participants
INTERVENTIONAL
2023-03-01
2025-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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:
1. Standard care
2. 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients
NCT05981222
Menopause Osteoporosis and Bone Intervention Using Lifestyle Exercise.
NCT04469374
Striving to be Strong: Self-management
NCT03405103
Assesment and Comparison of Osteoporosis Risk Factors After Stroke
NCT07228611
The Effect of Mechanical Loading on Bone Material Strength and Microarchitecture in Postmenopausal Women
NCT02339051
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard Care
Standard post-stroke care
Standard Care
Standard post-stroke care
Intervention
BOUNCE Program
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Standard Care
Standard post-stroke care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Higher Education, Malaysia
OTHER
Hospital Pengajar Universiti Putra Malaysia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sazlina Shariff-Ghazali, PhD
Role: STUDY_CHAIR
Universiti Putra Malaysia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Sultan Abdul Aziz Shah
Serdang, Selangor, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JKEUPM-2022-923
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.