SAFER Karachi - A Fall Prevention Intervention

NCT07504237 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-31

No results posted yet for this study

Summary

The goal of this pilot study is to evaluate the feasibility, acceptability, and short-term effects of a culturally adapted and strengthened fall prevention program in older adults aged 60 years and above living in urban Karachi, Pakistan. The study aims to understand whether a structured, community-based intervention can improve mobility, confidence, and overall well-being, while reducing the risk of falls.

The main questions it aims to answer are:

1. Is the adapted and strengthened fall prevention program feasible and acceptable for older adults in Karachi?
2. Does participation in the program improve mobility, balance, fall-related self-efficacy, and emotional well-being among participants?

Participants will:

1. Take part in a 7-week group-based fall prevention program that includes strength and balance exercises, home safety education, medication awareness, and behavioural strategies
2. Receive a follow-up home visit to reinforce safety practices and environmental modifications
3. Attend a booster session after 3 months to support continued engagement
4. Complete assessments at baseline and follow-up, including mobility, cognitive function, quality of life, and emotional well-being
5. Maintain monthly fall logs to report any fall incidents during the study period

Conditions

  • Accidental Falls
  • Falls
  • Falls Injury
  • Mobility Difficulty
  • Mobility and Independence
  • Aged 60 Years or Older

Interventions

BEHAVIORAL

Stepping On Fall Prevention Program

This intervention is a culturally adapted and contextually strengthened version of the evidence-based Stepping On fall prevention program, tailored for older adults in a low-resource urban setting. Unlike standard implementations, this version incorporates context-specific modifications based on local environmental, social, and health system realities in Karachi. Key distinguishing features include structured facilitator training to ensure standardized delivery, physiotherapist-informed guidance for exercise components to enhance safety, and integration of supportive tools to improve participant adherence and engagement. The intervention also includes follow-up reinforcement through home visits and a booster session to support sustained behaviour change. These adaptations are designed to improve feasibility, acceptability, and scalability of the intervention within resource-constrained settings while retaining the core evidence-based components of the original program.

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH
  • Aga Khan University

    lead OTHER

Principal Investigators

  • Sonia Sameen, MSc. · Aga Khan University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-04-30
Completion
2026-07-31

Countries

  • Pakistan

Study Locations

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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 NCT07504237 on ClinicalTrials.gov