RehabilitationNCT06505083
The Effect of Modified Stepping Trainings in Frailty Elderly With Physical Performance- a Prospective Randomized Controlled Trial
A study testing modified stepping trainings in people with Rehabilitation and Training, run by Chonticha Kaewjoho at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Training, Respiratory Muscle Strength
- What is being tested?
- modified stepping trainings
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- 25 Jun 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- people who were initially recruited, those diagnosed with dementia, depression, severe cardiovascular disease, or mental illness were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- modified stepping trainings
- Keywords
- balance ability, gait training, risk of falls, community-dwelling, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified stepping trainingsOther
Also called stable stepping, unstable stepping
step-up on box texture difference
| Study group | Role | What they receive |
|---|---|---|
| control grops | Sham comparator | stepping on stable step Receives: Other: modified stepping trainings |
| experimental group | Experimental | stepping on unstable step Receives: Other: modified stepping trainings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: pre test, 4 week, 6 week, 1 month follow up
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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
Measured: pre test, 4 week, 6 week, 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start25 Jun 2023
- Primary completion25 Dec 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonticha Kaewjoho
- Sponsor type
- University, hospital or other
- Collaborators
- Mae Fah Luang University, University of Phayao
- Responsible party
- Sponsor-investigator, Chonticha Kaewjoho, University of Phayao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505083
- Sponsor's protocol ID
- UPhayaoChonticha-218
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Modified Stepping Trainings in Frailty Elderly With Physical Performance- a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06505083
- Acronym / sponsor ID
- UPhayaoChonticha-218
- Conditions
- Rehabilitation, Training, Respiratory Muscle Strength
- Keywords
- balance ability, gait training, risk of falls, community-dwelling, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chonticha KaewjohoUniversity, hospital or other
- Collaborators
- Mae Fah Luang University, University of Phayao
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| control grops | Sham comparator | Other: modified stepping trainingsstepping on stable step |
| experimental group | Experimental | Other: modified stepping trainingsstepping on unstable step |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- people who were initially recruited, those diagnosed with dementia, depression, severe cardiovascular disease, or mental illness were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified stepping trainingsAlso: stable stepping, unstable steppingstep-up on box texture difference | Other | control grops, experimental group |
Primary outcome
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
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
3 secondary outcomes
Individual isometric muscle strength
Time frame: pre test, 4 week, 6 week, 1 month follow up
Back-leg-chest strength
Time frame: pre test, 4 week, 6 week, 1 month follow up
The 10-m Walk Test (10-m WT)
Time frame: pre test, 4 week, 6 week, 1 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified stepping trainings in people with Rehabilitation and Training, run by Chonticha Kaewjoho at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go test (TUGT) (time frame: pre test, 4 week, 6 week, 1 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.