Clinical trial NCT06505083: The Effect of Modified Stepping Trainings in Frailty Elderly With Physical Performance- a Prospective Randomized Controlled Trial
Official title: The Effect of Modified Stepping Trainings in Frailty Elderly With Physical Performance- a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Training
Respiratory Muscle Strength
Keywords: balance ability
gait training
risk of falls
community-dwelling
older adults
Lead sponsor: University of Phayao
Sponsor class: OTHER
Collaborators: name: Mae Fah Luang University
name: University of Phayao
First posted: 2024-07-17
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Timed up and go test (TUGT)
timeFrame: pre test, 4 week, 6 week, 1 month follow up
measure: The five-times-sit-to-stand (FTSTS) test
timeFrame: pre test, 4 week, 6 week, 1 month follow up
Secondary outcomes:
measure: Individual isometric muscle strength
timeFrame: pre test, 4 week, 6 week, 1 month follow up
measure: Back-leg-chest strength
timeFrame: pre test, 4 week, 6 week, 1 month follow up
measure: The 10-m Walk Test (10-m WT)
timeFrame: pre test, 4 week, 6 week, 1 month follow up
Other outcomes:
Locations:
city: Chiang Rai
country: Thailand
facility: Mar Fah Luang university
state: Chiangrai
Study officials:
References: