NCT07359378

Brief Summary

Study Design: Randomized Clinical Trial Objective: To find the effects of Progressive Resistance Exercises for balance and risk of falls in elderly population. To find the effects of Functional Training for balance and risk of falls in elderly population. To compare the effects of Progressive Resistance Exercises and Functional Training for balance and risk of falls in elderly population. Inclusion Criteria: Both Males and Female Patients Patients Age 65 years or above Participants with intact cognitive function or mild cognitive impairment who can follow instructions and provide informed consent Individuals medically cleared by their physician to engage in moderate-intensity physical activities, with no unstable medical conditions that could impede participation Participants willing to commit to an 8-week intervention program (3 sessions per week) and attend follow-ups as required. Exclusion Criteria: Elderly individuals who are non-ambulatory or unable to perform basic mobility tasks, such as standing or walking independently, even with assistive devices. Uncontrolled medical conditions such as uncontrolled hypertension, unstable angina, or severe arrhythmias. Participants with severe musculoskeletal conditions that significantly limit mobility or exercise participation (e.g., severe arthritis, recent fractures, or joint replacements within the last 6 months). Presence of acute pain or injury that may worsen with physical activity. Individuals with progressive neurological conditions such as Parkinson's disease, stroke with severe residual deficits, or multiple sclerosis that impede safe participation in physical activities. Group 1: Progressive Resistance Exercises Participants in the Progressive Resistance Training (PRT) group will engage in a structured exercise program designed to progressively increase muscle strength, balance, and overall physical function. Group 2: Functional Training Participants in the Functional Training (FT) group will engage in exercises that mimic daily activities to improve balance, strength, mobility, and functional independence.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

December 26, 2025

Last Update Submit

January 29, 2026

Conditions

Keywords

fallprogressive resistivefunctional training

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale (BBS)

    The BBS will evaluate static and dynamic balance through 14 functional tasks, such as standing, reaching, turning, and stepping. Each task is scored on a 5-point ordinal scale (0-4), with a total score of 56. A score of ≤45 will indicate an increased risk of falls, providing a comprehensive measure of postural stability and balance control.

    from enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Timed Up and Go Test

    from enrollment till the end of treatment at 8 weeks

  • Falls Risk Assessment Tool FRAT

    From enrollment the end of treatment at 8 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Progressive Resistance Training

Other: Progressive Resistance Training

Group 2

EXPERIMENTAL

Functional Training

Other: Functional Training

Interventions

Intervention Protocol 1. Warm-Up (5 minutes) Gentle aerobic activities (marching in place, arm swings). Dynamic stretching to prepare muscles for resistance exercises. 2. Main Phase (35 minutes) Progressive resistance exercises targeting major muscle groups, applying the progressive overload principle (increasing resistance or repetitions biweekly). Exercises will include: o Lower body: Squats, seated leg press. o Upper body: Bicep curls, tricep extensions using dumbbells or resistance bands. o Core strengthening: Bridges. Focus on controlled movements and proper form to minimize injury risk. 19 3. Cooldown (5 minutes) Static stretching for major muscle groups to improve flexibility and promote recovery. (Coleman et al., 2021)

Group 1

1\. Warm-Up (5 minutes) Light walking in place, arm swings, and shoulder rolls to prepare the body. Dynamic stretching focusing on key muscle groups. 2. Main Phase (35 minutes) Exercises designed to enhance functional movements for daily activities: Sit-to-Stand (Chair Squats) - Strengthens legs and mimics standing up from a chair. Step-Ups - Improves leg strength and balance for climbing stairs. Heel-to-Toe Walk - Enhances balance and gait stability. Wall Push-Ups - Strengthens upper body for pushing movements. Bicep Curls with Resistance Bands - Improves arm strength for carrying objects. Ankle Circles - Enhances ankle mobility and balance. Progressive difficulty will be applied by increasing repetitions, reducing support, or adding light resistance. 3. Cooldown (5 minutes) 20 21 Gentle static stretching for major muscle groups. Breathing exercises for relaxation. (Ritterfeld et al., 2010)

Group 2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Both Males and Female Patients
  • Patients Age 65 years or above
  • Participants with intact cognitive function or mild cognitive impairment who can follow instructions and provide informed consent
  • Individuals medically cleared by their physician to engage in moderate-intensity physical activities, with no unstable medical conditions that could impede participation
  • Participants willing to commit to an 8-week intervention program (3 sessions per week) and attend follow-ups as required.

You may not qualify if:

  • Elderly individuals who are non-ambulatory or unable to perform basic mobility tasks, such as standing or walking independently, even with assistive devices.
  • Uncontrolled medical conditions such as uncontrolled hypertension, unstable angina, or severe arrhythmias.
  • Participants with severe musculoskeletal conditions that significantly limit mobility or exercise participation (e.g., severe arthritis, recent fractures, or joint replacements within the last 6 months).
  • Presence of acute pain or injury that may worsen with physical activity. Individuals with progressive neurological conditions such as Parkinson's disease, 15 stroke with severe residual deficits, or multiple sclerosis that impede safe participation in physical activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study will implement single-blinding, where outcome assessors will remain unaware of group assignments to reduce assessment bias. Participants and session supervisors will not be blinded due to the nature of the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 26, 2025

First Posted

January 22, 2026

Study Start

January 1, 2026

Primary Completion

March 3, 2026

Study Completion

March 10, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01