UMIN-ICDS Clinical Trial

Public title

Comparative Effects of 6-Week Core Stability and Dynamic Neuromuscular Stabilization Training on Muscular Endurance and Intrinsic Capacity in Community-Dwelling Older Women: A Randomized Controlled Trial

Acronym

Core Stability

Scientific Title

Comparative Effects of 6-Week Core Stability and Dynamic Neuromuscular Stabilization Training on Muscular Endurance and Intrinsic Capacity in Community-Dwelling Older Women: A Randomized Controlled Trial

Scientific Title:Acronym

Core Stability

Region

Asia(except Japan)

Condition

Community-Dwelling Older Women:

Classification by specialty

Operative medicine	Rehabilitation medicine	Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The primary objective of this randomized controlled trial was to compare the effects of a 6-week DNS program versus a traditional CS program on trunk muscular endurance and WHO-defined intrinsic capacity in community-dwelling older women.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Core Muscle Endurance (Muscular Endurance):

Trunk Flexor Endurance Test (anterior core - rectus abdominis)

Sorensen Test (posterior core - erector spinae endurance)

Side Plank Tests (Left and Right) (lateral core - quadratus lumborum endurance)


2. Intrinsic Capacity (IC) - WHO-defined composite:

Locomotion: Short Physical Performance Battery (SPPB) - scores 0-12

Cognitive function: Montreal Cognitive Assessment (MoCA) - 30-point scale

Psychological function: Geriatric Depression Scale (GDS-15) - 15-item scale

Vitality: Handgrip strength (kilograms)

Sensory domain: Self-reported visual and hearing impairments (scored 0-2)

Composite IC z-score: Calculated by summing z-scores of locomotion, cognition, psychological (GDS weighted -1), and vitality domains, divided by four

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Core Stability (CS) Training
The CS group performed a 6-week program (three 45-minute sessions per week) consisting of traditional core exercises, including half sit-ups, rotational sit-ups, side bridges, prone bridges (planks), leg raises, Bird-Dog, Dead Bug, standing anti-rotation press, and heel slides. The protocol emphasized isometric contractions and targeted activation of deep abdominal and paraspinal musculature to enhance lumbopelvic control and static balance. Progression was guided by qualitative movement mastery, proper alignment, and fatigue management rather than fixed external loads. Sessions were supervised by a certified MSc sport scientist, and adherence exceeded 90%.

Interventions/Control_2

Dynamic Neuromuscular Stabilization (DNS) Training
The DNS group completed a 6-week program (three 45-minute sessions per week) based on developmental kinesiology principles, incorporating diaphragmatic breathing in supine 90-90 position, Baby Rock, controlled rolling patterns, side-lying reach, three-point kneeling, half-kneeling with reach, functional squats, and progressive Czech Get-Ups. The intervention focused on restoring optimal intra-abdominal pressure, reflexive spinal stabilization, and coordinated diaphragmatic breathing. Progression was determined by mastery of developmental movement patterns and ability to maintain proper breathing mechanics during dual-task conditions. Sessions were supervised by a certified DNS sport scientist, with adherence exceeding 90%.

Interventions/Control_3

The control group did not receive any intervention and was asked to continue their normal daily routines without participating in any structured exercise throughout the study period. They were also clearly advised not to begin any new physical activity or exercise programs during this time.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

60

years-old

<=

Age-upper limit

80

years-old

>

Gender

Female

Key inclusion criteria

Community-dwelling older women

Age over 60 years

Ability to communicate effectively

Ability to walk independently for at least 10 meters (with or without assistive devices)

No regular physical exercise during the previous six months (defined as at least two sessions per week, 20 minutes per session)

Key exclusion criteria

Unstable cardiovascular disease

Uncontrolled hypertension

Recent pulmonary thromboembolism

Neurological or vestibular disorders

Significant visual or hearing impairments

Severe musculoskeletal problems

History of lower extremity surgery or fractures in the upper or lower limbs within the past three months

Target sample size

36

Name of lead principal investigator

1st name	Hossein
Middle name
Last name	Shahrokhi

Organization

Department of Sports Injury and Corrective Exercises, Faculty of Sport Sciences, Hakim Sabzevari University

Division name

Department of Sports Injury and Corrective Exercises

Zip code

9617976487

Address

Department of Sports Injury and Corrective Exercises, Faculty of Sport Sciences, Hakim Sabzevari University, Sabzevar, Iran

TEL

+985144012756

Email

h.shahrokhi@hsu.ac.ir

Name of contact person

1st name	Hossein
Middle name
Last name	Shahrokhi

Organization

Department of Sports Injury and Corrective Exercises, Faculty of Sport Sciences, Hakim Sabzevari Uni

Division name

Department of Sports Injury and Corrective Exercises

Zip code

9617976487

Address

Department of Sports Injury and Corrective Exercises, Faculty of Sport Sciences, Hakim Sabzevari Uni

TEL

+985144012756

Homepage URL

Email

h.shahrokhi@hsu.ac.ir

Institute

Hakim Sabzevari University

Institute

Department

Personal name

Organization

Hossein Shahrokhi

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hakim Sabzevari University

Address

Sabzevar city at Razavi Khorasan province, Iran

Tel

+98 51 4441 0104

Email

h.shahrokhi@hsu.ac.ir

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

07

Day

URL releasing protocol

221212

Publication of results

Unpublished

URL related to results and publications

23232

Number of participants that the trial has enrolled

36

Results

The composite IC z-score (p < .001, eta p2 = 0.58-0.71), but not for handgrip strength (p = 0.53). Post-hoc comparisons showed that both the DNS and CS groups significantly outperformed the control group in nearly all outcomes (p <= 0.010), with improvements in trunk flexion endurance (DNS: +3.45 s; CS: +3.27 s), left/right side plank endurance (DNS: 7.34-7.74 s; CS: 7.27-7.67 s)

Results date posted

2026

Year

05

Month

10

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

At baseline, the three groups (Control, Core Stability [CS], and Dynamic Neuromuscular Stabilization [DNS]), each consisting of 12 community-dwelling older women, were homogeneous with no statistically significant differences in demographic or functional measures (p > 0.05 for all comparisons). The mean age of participants was 65.58 +/- 2.74 years in the control group, 64.75 +/- 3.07 years in the CS group, and 65.83 +/- 3.78 years in the DNS group (p = 0.69). Mean weight and height were also similar across groups, ranging from 66.25 kg to 69.08 kg and 165.00 cm to 165.66 cm, respectively. Regarding functional outcomes at pre-test, all groups showed comparable performance on trunk flexion endurance (approximately 20-21 seconds), Sorensen back extensor test (approximately 21 seconds), side plank tests (approximately 20-22 seconds), MoCA cognitive scores (approximately 21.6 points), SPPB physical function scores (approximately 11.5 points), GDS depression scores (approximately 3.3-3.9 points), handgrip strength (approximately 24-25 kg), and intrinsic capacity z-scores (approximately -0.05 to 0.08). These findings confirmed baseline homogeneity, which is essential for valid group comparisons in this randomized controlled trial.

Participant flow

A total of 36 community-dwelling older women were enrolled and randomly allocated equally into three groups: Control (n=12), Core Stability (CS) (n=12), and Dynamic Neuromuscular Stabilization (DNS) (n=12). Recruitment took place in Tehran, Iran, between February 1 and March 31, 2022, through flyers, public announcements, and newspaper advertisements. All 36 participants completed the 6-week study period with no losses to follow-up, no discontinuations, and no adverse events reported in any group. Adherence to the supervised training sessions was high, exceeding 90% in both intervention groups (CS and DNS). The control group received no intervention and continued their normal daily routines. All participants were included in the per-protocol analysis, as no participants were excluded or withdrawn from the study.

Adverse events

Both the Core Stability (CS) and Dynamic Neuromuscular Stabilization (DNS) training programs appeared to be safe and well-tolerated by all 36 community-dwelling older women participants, with no adverse events reported throughout the 6-week intervention period.

Outcome measures

The primary outcome measures in this randomized controlled trial included trunk muscular endurance assessed by the Trunk Flexor Endurance Test, Sorensen Test, and left/right Side Plank Tests (all timed up to 120 seconds maximum), as well as World Health Organization-defined intrinsic capacity (IC) evaluated through the Short Physical Performance Battery (SPPB) for locomotion, Montreal Cognitive Assessment (MoCA) for cognition, Geriatric Depression Scale (GDS-15) for psychological function, handgrip strength for vitality, and a composite IC z-score calculated from these domains. All outcomes were measured at baseline (pre-test) and immediately following the 6-week intervention period (post-test). Regarding the requirement to register summary results within 12 months of the date on which final data were collected, the manuscript does not report whether this was complied with. Based on the reported timeline, final data collection was completed around May 2022 (6 weeks after recruitment ended on March 31, 2022), meaning summary results should have been registered in the Iranian Registry of Clinical Trials (IRCT20200107046035N8) by approximately May 2023. However, the manuscript provides no confirmation of whether results were posted by that deadline, nor does it provide a direct URL to the summary results.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2022

Year

01

Month

12

Day

Date of IRB

2022

Year

01

Month

02

Day

Anticipated trial start date

2022

Year

02

Month

01

Day

Last follow-up date

2022

Year

05

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

05

Month

10

Day

Last modified on

2026

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070385