Bone LossBOUNCENCT05939531
Multi-domain Intervention Program for Post-stroke Bone Health in Older Adults (BOUNCE)
A study testing BOUNCE Program in people with Bone Loss and Stroke, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bone Loss, Stroke, Geriatrics
- What is being tested?
- BOUNCE Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2023to 31 Aug 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Sultan Abdul Aziz Shah
Serdang, Selangor, 43400
Hakimah Mohammad Sallehuddin, MBBS, +60397692893 ext. 2568, drhakimah@upm.edu.my
Sazlina Shariff-Ghazali, PhD, sazlina@upm.edu.my
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Bone Loss, Stroke, Geriatrics
- Being tested
- BOUNCE Program, Standard Care
- Keywords
- Feasibility, Bone Loss, Intervention, Geriatrics, Stroke
- Medical subject headings
- Bone Diseases, Metabolic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOUNCE ProgramBehavioural
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 CareBehavioural
Standard post-stroke care
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Standard post-stroke care Receives: Behavioral: Standard Care |
| Intervention | Experimental | BOUNCE Program Receives: Behavioral: BOUNCE Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and month-6
Secondary outcomes (8)
Recruitment uptake
Number of participants randomized among screened
Measured: 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
To examine the difference of BTM change pre and post-intervention between groups
Measured: At baseline and month-6
Retention
Number of participants followed-up among randomized
Measured: Assessment at month-4 and month-6
Treatment adherence
Number of participants who adhere to the nutritional and exercise interventions in each group
Measured: 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
Measured: Assessment at month-4 and month-6
Side-effects
Qualitative study using a semi-structured interview on any side effects of the intervention
Measured: Assessment at month-4 and month-6
Falls
Number of participants experiencing falls during the study period as assessed by Falls Diary
Measured: 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
Measured: Assessment at month-4 and month-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Mar 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Pengajar Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Responsible party
- Sponsor
- Investigators
- Sazlina Shariff-Ghazali, PhD, Study chair, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939531
- Sponsor's protocol ID
- JKEUPM-2022-923
- Acronym
- BOUNCE
- Status last verified
- Jan 2024
- First submitted
- 7 Mar 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05939531
- Acronym / sponsor ID
- BOUNCE / JKEUPM-2022-923
- Conditions
- Bone Loss, Stroke, Geriatrics
- Keywords
- Feasibility, Bone Loss, Intervention, Geriatrics, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital Pengajar Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 11 Jul 2023 (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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard CareStandard post-stroke care |
| Intervention | Experimental | Behavioral: BOUNCE ProgramBOUNCE Program |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| BOUNCE ProgramIntervention 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. | Behavioural | Intervention |
| Standard CareStandard post-stroke care | Behavioural | Standard Care |
Primary outcome
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
8 secondary outcomes
Recruitment uptake
Time frame: 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
Retention
Time frame: Assessment at month-4 and month-6
Treatment adherence
Time frame: Assessment at month-4 and month-6
Acceptability
Time frame: Assessment at month-4 and month-6
Side-effects
Time frame: Assessment at month-4 and month-6
Falls
Time frame: Assessment at month-4 and month-6
Fracture
Time frame: Assessment at month-4 and month-6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- 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.
Sazlina Shariff-Ghazali, PhD study chair
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOUNCE Program in people with Bone Loss and Stroke, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.
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 13 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 25 Jan 2024. 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 Malaysia. 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 Hakimah Mohammad Sallehuddin, MBBS (+60397692893 ext. 2568, drhakimah@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 25 Jan 2024.