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Completed

NCT Number: NCT06505083

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mar Fah Luang university

Chiang Rai, Chiangrai, 57100, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

modified stepping trainings

Other

step-up on box texture difference

Other names: stable stepping, unstable stepping

Primary outcomes

  1. Timed up and go test (TUGT)

    Time frame: pre test, 4 week, 6 week, 1 month follow up

    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

  2. The five-times-sit-to-stand (FTSTS) test

    Time frame: pre test, 4 week, 6 week, 1 month follow up

    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

Secondary outcomes

  1. Individual isometric muscle strength

    Time frame: pre test, 4 week, 6 week, 1 month follow up

    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)

  2. Back-leg-chest strength

    Time frame: pre test, 4 week, 6 week, 1 month follow up

    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.

  3. The 10-m Walk Test (10-m WT)

    Time frame: pre test, 4 week, 6 week, 1 month follow up

    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

Sponsors and collaborators

Lead sponsor

Chonticha Kaewjoho

Other

Collaborators

  • Mae Fah Luang University
  • University of Phayao

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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