The Effect of Modified Stepping Trainings in Frailty Elderly With Physical Performance- a Prospective Randomized Controlled Trial

This single-blind, randomized controlled trial compared the effects of modifiled stepping exercise training on flat step and unstable step on the functional outcomes in community-dwelling older adults. The subjects were involved in a step up in 4 directions exercise on each surface, according to their groups, for 50 min/day, 3 days/week, for 6 weeks. The functional outcomes were assessed prior to training, at Week 3, Week 6 after training and 1 months after training.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Training; Respiratory Muscle Strength
• Intervention / Treatment: Other: modified stepping trainings

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chiangrai
    • Chiang Rai, Chiangrai, Thailand, 57100
      • Mar Fah Luang university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The eligible participants needed ability of independent walking over at least 10 m without any assistive devices, and did not participate in a regular exercise program prior to being involved in the study. Older individuals who presented any signs and symptoms that might affect walking and the ability to participate in the study, such as unstable medical conditions, inflammation in the joints of the lower extremities (with a pain scale of more than 5 out of 10 on a visual analog scale), and having sequelae of neurological deficits, were excluded from the study

Exclusion Criteria:

• people who were initially recruited, those diagnosed with dementia, depression, severe cardiovascular disease, or mental illness were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control grops; stepping on stable step	Other: modified stepping trainings; step-up on box texture difference; Other Names: stable stepping; unstable stepping
Experimental: experimental group; stepping on unstable step	Other: modified stepping trainings; step-up on box texture difference; Other Names: stable stepping; unstable stepping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go test (TUGT)	The study subjects were instructed to sit on a chair (46cm height) without arm rest. They were instructed to get up from chair on command, walk at a comfortable pace, walk around the cone which was marked 3m ahead and return to a seated position on the original chair. The stop watch was started as soon as the subject lifted buttocks off the chair and it was stopped at the point where the subject sat back in the chair after completing walking. The total time taken by each subject to complete the task was noted as the final score	pre test, 4 week, 6 week, 1 month follow up
The five-times-sit-to-stand (FTSTS) test	a simple and quick test initially designed to be a proxy measure of lower-limb strength. The test requires a subject to stand up and sit down five times as quickly as possible from a chair with a seat 43-cm high. The time taken to complete the test (the FTSTS scores) is recorded with a stopwatch. Excellent test-retest reliability of FTSTS scores (intraclass correlation coefficient (ICC) 0.933) has been reported in people with chronic stroke and community-dwelling older adults (ICC 0.89- 0.96). Several other studies have demonstrated the reliability or validity or both of FTSTS scores in specific subject populations, including Parkinson's disease (Duncan et al., 2011) and renal pathologies and subjects with rheumatoid arthritis and balance disorders	pre test, 4 week, 6 week, 1 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual isometric muscle strength	The strength of maximum isometric voluntary contraction of the subject's hip flexor, extensor, adductor, abductor, knee flexor, extensors, ankle dorsiflexors, and plantar flexors (in kilograms) was measured using a Nicholas handheld dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN). The Nicholas HHD is a digital force gauge capable of measuring forces from 0.0 to 199.99 kg. The measurement protocol was as described by (Magalhães et al., 2012)	pre test, 4 week, 6 week, 1 month follow up
Back-leg-chest strength	A calibrated BLC dynamometer (The Takei 5402 Back Muscle Digital Dynamometer) measures isometric muscle strength, recorded in kilograms (kg) of force. There is excellent test-retest reliability (ICC = .98) for leg extension strength (Ten Hoor et al., 2016). The dial ranges from 0 to 300 kg (0 to 660 lb) in 10 kg (10 lb) increments. For the test, the length of the chain was adjusted to the participants' height by asking the subject to stand on the base of the BLC dynamometer with extended knees. Subsequently, the handle was positioned at the height of the intra-articular space of the knee joint. For the test, participants had to stand on the base, with knees and hips flexed slightly while the lower back had to maintain an appropriate lordotic curve.	pre test, 4 week, 6 week, 1 month follow up
The 10-m Walk Test (10-m WT)	This test generally evaluates the gait velocity of patients with neurological damage and shows high inter-rater and intra-rater reliability (r=0.89-1.00) (Lang et al., 2016; Saito et al., 2022). In the present study, the subjects were instructed to individuals performed three 10-m overground walk trials timed with a stopwatch in each comfortable and maximum speeds to characterize our participant sample. For comfortable walking speed, individuals were instructed to "walk at a speed that feels the most comfortable" and for maximum speed individuals were instructed to "walk at the fastest speed you feel safe" walk 10 m; the time taken for 4 m, excluding the first 3 m and the last 3 m, which take into account acceleration and deceleration, was measured in units of seconds	pre test, 4 week, 6 week, 1 month follow up

Collaborators and Investigators

• Sponsor: Chonticha Kaewjoho
• Collaborators: University of Phayao; Mae Fah Luang University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2023
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: older adults; community-dwelling; gait training; risk of falls; balance ability
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: UPhayaoChonticha-218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No