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

NCT06505083 | Completed

• 1 other identifier: UPhayaoChonticha-218
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rehabilitation; Training; Respiratory Muscle Strength

Keywords

balance ability; gait training; risk of falls; community-dwelling; older adults

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Individual isometric muscle strength

  pre test, 4 week, 6 week, 1 month follow up

• Back-leg-chest strength

  pre test, 4 week, 6 week, 1 month follow up

• The 10-m Walk Test (10-m WT)

  pre test, 4 week, 6 week, 1 month follow up

Study Arms (2)

control grops

SHAM COMPARATOR

stepping on stable step

Other: modified stepping trainings

experimental group

EXPERIMENTAL

stepping on unstable step

Other: modified stepping trainings

Interventions

modified stepping trainings OTHER

step-up on box texture difference

Also known as: stable stepping, unstable stepping

control grops; experimental group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chonticha Kaewjoho: lead
• Mae Fah Luang University: collaborator
• University of Phayao: collaborator

Study Sites (1)

Mar Fah Luang university

Chiang Rai, Chiangrai, 57100, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Allied Health Sciences

Model Details: This prospective randomized controlled trial design was conducted in thirty-two community-dwelling older participants who completed a modified stepping exercises program for 50 minutes/day, three days/week over six weeks. They were assessed for their functional mobility relating to levels of independence and prospectively followed up periods one month. RESULTS: The participants in our study demonstrated significant improvements in their functional mobility after within 4 weeks of training, and these improvements continued to increase by week 6 (p\<0.01). Notably, the participants showed significant improvements in all functional outcomes at week 4, week 6, and one-month follow-up (p\<0.05). The most significant improvements were observed in the FTSST, TUGT, and lower limb muscle strength, and these outcomes were significantly different from the pre-test and intermediate tests (p\<0.01).

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: June 25, 2023
• Primary Completion: December 25, 2023
• Study Completion: March 30, 2024
• Last Updated: August 15, 2025

Record last verified: 2024-07

Locations

TH (1)