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

NCT05939531 | Unknown

• 1 other identifier: JKEUPM-2022-923
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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:
• 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.

Conditions

Bone Loss; Stroke; Geriatrics

Keywords

Feasibility; Bone Loss; Intervention; Geriatrics; Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Recruitment uptake

  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

  At baseline and month-6

• Retention

  Assessment at month-4 and month-6

• Treatment adherence

  Assessment at month-4 and month-6

• Acceptability

  Assessment at month-4 and month-6

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Standard post-stroke care

Behavioral: Standard Care

Intervention

EXPERIMENTAL

BOUNCE Program

Behavioral: BOUNCE Program

Interventions

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.

Intervention

Standard Care BEHAVIORAL

Standard post-stroke care

Standard Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Pengajar Universiti Putra Malaysia: lead
• Ministry of Higher Education, Malaysia: collaborator

Study Sites (1)

Hospital Sultan Abdul Aziz Shah

Serdang, Selangor, 43400, Malaysia

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic; Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sazlina Shariff-Ghazali, PhD

  Universiti Putra Malaysia

  STUDY CHAIR

Central Study Contacts

Hakimah Mohammad Sallehuddin, MBBS

CONTACT

+60397692893; drhakimah@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: July 11, 2023
• Study Start: March 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: August 31, 2025
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)