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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06505083
Enrollment
32
Registered
2024-07-17
Start date
2023-06-25
Completion date
2024-03-30
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation, Respiratory Muscle Strength, Training

Keywords

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

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.

Interventions

OTHERmodified stepping trainings

step-up on box texture difference

Sponsors

Mae Fah Luang University
CollaboratorOTHER
University of Phayao
CollaboratorOTHER
Chonticha Kaewjoho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Timed up and go test (TUGT)pre test, 4 week, 6 week, 1 month follow upThe 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
The five-times-sit-to-stand (FTSTS) testpre test, 4 week, 6 week, 1 month follow upa 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

MeasureTime frameDescription
Individual isometric muscle strengthpre test, 4 week, 6 week, 1 month follow upThe 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)
Back-leg-chest strengthpre test, 4 week, 6 week, 1 month follow upA 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.
The 10-m Walk Test (10-m WT)pre test, 4 week, 6 week, 1 month follow upThis 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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026