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Multi-domain Intervention Program for Post-stroke Bone Health in Older Adults (BOUNCE) (BOUNCE)

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ClinicalTrials.gov Identifier: NCT05939531
Recruitment Status : Recruiting
First Posted : July 11, 2023
Last Update Posted : January 25, 2024
Sponsor:
Collaborator:
Ministry of Higher Education, Malaysia
Information provided by (Responsible Party):
Hospital Pengajar Universiti Putra Malaysia

Study Description
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Brief 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. 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:

  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.

Condition or disease Intervention/treatment Phase
Bone Loss Stroke Geriatrics Behavioral: BOUNCE Program Behavioral: Standard Care Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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)
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Care
Standard post-stroke care
 Behavioral: Standard Care
Standard post-stroke care
Experimental: Intervention
BOUNCE Program
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Recruitment uptake [ Time Frame: Throughout study period of average 1 year ]
    Number of participants randomized among screened

  2. 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

  3. Retention [ Time Frame: Assessment at month-4 and month-6 ]
    Number of participants followed-up among randomized

  4. 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

  5. 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

  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

  7. Falls [ Time Frame: Assessment at month-4 and month-6 ]
    Number of participants experiencing falls during the study period as assessed by Falls Diary

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05939531


Contacts
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Contact: Hakimah Mohammad Sallehuddin, MBBS +60397692893 ext 2568 drhakimah@upm.edu.my

Locations
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Malaysia
Hospital Sultan Abdul Aziz Shah Recruiting
Serdang, Selangor, Malaysia, 43400
Contact: Hakimah Mohammad Sallehuddin, MBBS    +60397692893 ext 2568    drhakimah@upm.edu.my   
Contact: Sazlina Shariff-Ghazali, PhD       sazlina@upm.edu.my   
Sponsors and Collaborators
Hospital Pengajar Universiti Putra Malaysia
Ministry of Higher Education, Malaysia
Investigators
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Study Chair: Sazlina Shariff-Ghazali, PhD Universiti Putra Malaysia
More Information
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Responsible Party: Hospital Pengajar Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT05939531    
Other Study ID Numbers: JKEUPM-2022-923
First Posted: July 11, 2023    Key Record Dates
Last Update Posted: January 25, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Pengajar Universiti Putra Malaysia:
Feasibility
Bone Loss
Intervention
Geriatrics
Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases