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

NCT05939531 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-01-25

No results posted yet for this study

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.

Conditions

Interventions

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.

BEHAVIORAL

Standard Care

Standard post-stroke care

Sponsors & Collaborators

  • Ministry of Higher Education, Malaysia

    collaborator OTHER

  • Hospital Pengajar Universiti Putra Malaysia

    lead OTHER

Principal Investigators

  • Sazlina Shariff-Ghazali, PhD · Universiti Putra Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-11-30
Completion
2025-08-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05939531 on ClinicalTrials.gov