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Stress Modulation and Dynamic Balance

29 kwietnia 2026 zaktualizowane przez: Ammar Sobhy Farag Ghallab, Kafrelsheikh University

Impact of Dual Task Therapeutic Exercises on Stress Modulation and Dynamic Balance in University Students

This three-arm, parallel-group, randomized controlled trial (RCT) investigates whether dual-task therapeutic exercises (dynamic balance + cognitive task) improve perceived stress and dynamic balance in 72 healthy university students (18-25 years) compared to traditional balance training alone or a control group receiving general health advice. The dual-task group performs the same dynamic balance exercises (e.g., backward walking, tandem gait, single-leg reaches) while simultaneously engaging in cognitive tasks (verbal fluency, arithmetic, or working memory). The intervention lasts 6 weeks (2 sessions/week, 20-30 min each). Primary outcomes are Perceived Stress Scale (PSS-10) scores and objective dynamic balance indices (anterior/posterior/lateral deviation, overall stability) measured via the Balance check 636 device. Assessments occur at baseline and post-intervention by a blinded assessor. The study addresses a gap: no prior trial has examined combined effects of dual-task training on both stress modulation and balance in this population.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Study Design

  • Type: Pre-post RCT, three parallel groups (n=24 each).
  • Setting: Outpatient Clinic & Balance Laboratory, Faculty of Physical Therapy, Kafr Elsheikh University.
  • Blinding: Assessor blinded to group allocation.

Population & Eligibility

  • Sample: 72 students (both sexes), age 18-25, BMI 18.5-29.9.
  • Inclusion: Free from neurological, musculoskeletal, or psychiatric disorders; willing to comply.
  • Exclusion: Lower limb/spine injury/surgery (past 6 months), vestibular disorders, pregnancy, medications affecting balance/cognition, regular balance or mind-body training in past 6 months.

Randomization & Groups

  • Computer-generated block randomization with opaque sealed envelopes.
  • Group A (Balance only): dynamic balance exercises (backward walking, lateral stepping, single-leg forward/lateral reach, tandem gait).
  • Group B (Dual-task): same balance exercises plus concurrent cognitive tasks: verbal fluency (e.g., name words starting with letter 'S'), arithmetic (e.g., subtract 7 from 100), or working memory (digit span backward). Cognitive tasks varied across sessions.
  • Group C (Control): general health advice (regular daily activities, sleep, nutrition, avoid excessive stress); no structured exercise.

Intervention Protocol

  • Duration: 6 weeks, twice/week, each session 20-30 minutes.
  • Progression Not Explicitly Stated - but exercises are fixed (10 repetitions or 5-10 m distance per item).
  • Safety: Arms crossed over chest in most exercises to eliminate upper limb compensation.

Outcome Measures (assessed at baseline & week 6)

  • Primary - Perceived Stress: Arabic PSS-10 (0-40, higher = worse).
  • Primary - Dynamic Balance: Balance check 636 (multiaxial wobble board with real-time software) - records anterior/posterior/right/left average deviations and overall stability index.
  • Anthropometric: Weight, height, BMI via standard scale.

Statistical Analysis

  • Software: SPSS v26.
  • Normality: Shapiro-Wilk test.
  • Within-group: Paired t-test or Wilcoxon signed-rank.
  • Between-groups (post-intervention): One-way ANOVA or Kruskal-Wallis; post-hoc with Bonferroni.
  • Power: G*Power (α=0.05, power=0.9, effect size 0.46) → n=72 (24/group, allowing 10% dropout).
  • Significance level: p < 0.05.

Hypotheses (Null)

  • No significant effect of dual-task exercises on stress modulation or dynamic balance.
  • No significant difference between dual-task and balance-only groups.

Limitations Noted in Protocol

  • No long-term follow-up.
  • Single-site, student population (limited generalizability).
  • No objective stress biomarker (only self-report PSS).

Timeline & Ethics

  • Participants sign informed consent (Helsinki protocol). Voluntary withdrawal allowed without justification.
  • Study period: not explicitly dated; protocol submitted 2026 for master's degree.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

72

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  • Participants will be included if they meet the following criteria:

Age between 18 and 25 years. Body Mass Index (BMI) ranging from 18.5 to 29.9 kg/m². Both males and females. Apparently healthy individuals with no diagnosed neurological, musculoskeletal, or psychological disorders.

Ability to understand instructions and provide informed consent. Willingness to participate and comply with the study protocol.

Exclusion Criteria:

  • Participants will be excluded if they have any of the following:

Any neurological disorder affecting balance (e.g., vestibular disorders, Parkinson's disease, multiple sclerosis, peripheral neuropathy).

Any recent musculoskeletal injury (within the last 6 months) affecting the lower limbs or spine.

History of lower limb or spinal surgery. Severe visual or auditory impairment not corrected by aids. Use of medications that may affect balance or cognitive function (e.g., sedatives, antidepressants, anxiolytics, antipsychotics).

Pregnancy. Uncontrolled cardiovascular or respiratory disorders limiting exercise tolerance.

Current diagnosis of major psychiatric disorders (e.g., major depression, generalized anxiety disorder, panic disorder).

Regular participation in balance training, mind-body exercises (e.g., yoga, Pilates, tai chi), or structured stress management programs within the last 6 months.

Participation in another interventional study at the same time.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Dynamic Balance Training Only

Participants perform a structured set of dynamic balance exercises under single-task conditions (motor task only). Exercises include:

  1. Controlled Backward Walking (CBW): Walk backward in a straight line (5-10 meters) using a toe-heel strike pattern; maintain upright trunk, head forward, arms naturally at sides.
  2. Controlled Lateral Dynamic Stepping (CLDS): Step sideways along a 5-meter path; feet shoulder-width apart, knees slightly flexed, hands clasped at chest; gaze fixed forward.
  3. Single-Leg Forward Reach (SLFR): Stand on one limb, hands crossed over chest; reach the non-standing leg forward to touch the floor with toes, return without losing balance. 10 repetitions per leg.
  4. Single-Leg Lateral Reach (SLSR): Same as SLFR but reaching sideways (lateral abduction). 10 repetitions per leg.
  5. Dynamic Tandem Gait (DTG): Walk heel-to-toe in a straight line (3-5 meters) with hands crossed over chest; gaze fixed forward.

Delivery: In-person, supervised by a trained physical ther
Inny: Dynamic Balance Training Only

Participants perform a structured set of dynamic balance exercises under single-task conditions (motor task only). Exercises include:

  1. Controlled Backward Walking (CBW): Walk backward in a straight line (5-10 meters) using a toe-heel strike pattern; maintain upright trunk, head forward, arms naturally at sides.
  2. Controlled Lateral Dynamic Stepping (CLDS): Step sideways along a 5-meter path; feet shoulder-width apart, knees slightly flexed, hands clasped at chest; gaze fixed forward.
  3. Single-Leg Forward Reach (SLFR): Stand on one limb, hands crossed over chest; reach the non-standing leg forward to touch the floor with toes, return without losing balance. 10 repetitions per leg.
  4. Single-Leg Lateral Reach (SLSR): Same as SLFR but reaching sideways (lateral abduction). 10 repetitions per leg.
  5. Dynamic Tandem Gait (DTG): Walk heel-to-toe in a straight line (3-5 meters) with hands crossed over chest; gaze fixed forward.

Delivery: In-person, supervised by a trained physical thera
Eksperymentalny: Dual task therapeutic exercises

Arm B: Dual-Task Therapeutic Exercise Group

Intervention Type: Other (Dual-Task Training)

Intervention Name: Dual-Task Therapeutic Exercise

Description:

Participants perform exactly the same dynamic balance exercises as Arm A, but simultaneously with a secondary cognitive task (dual-task condition). The cognitive task is performed throughout the duration of each balance exercise. Cognitive tasks are varied across sessions to maintain engagement and avoid habituation, and include:

  • Verbal Fluency Task: e.g., "Name as many words as you can starting with the letter 'S'" or "Name as many animals/fruits/cities."
  • Arithmetic Task: e.g., "Count backwards from 100 by 7" or "Subtract 3 from 50, then 3 from that number, and so on."
  • Working Memory Task: The therapist reads a list of numbers or words; the participant recalls them in reverse order (digits backward).

Delivery: In-person, supervised by the same trained physical therapist as Arm A.

Frequency & Duration: Twice weekly for 6
Inny: Dynamic Balance Training Only

Participants perform a structured set of dynamic balance exercises under single-task conditions (motor task only). Exercises include:

  1. Controlled Backward Walking (CBW): Walk backward in a straight line (5-10 meters) using a toe-heel strike pattern; maintain upright trunk, head forward, arms naturally at sides.
  2. Controlled Lateral Dynamic Stepping (CLDS): Step sideways along a 5-meter path; feet shoulder-width apart, knees slightly flexed, hands clasped at chest; gaze fixed forward.
  3. Single-Leg Forward Reach (SLFR): Stand on one limb, hands crossed over chest; reach the non-standing leg forward to touch the floor with toes, return without losing balance. 10 repetitions per leg.
  4. Single-Leg Lateral Reach (SLSR): Same as SLFR but reaching sideways (lateral abduction). 10 repetitions per leg.
  5. Dynamic Tandem Gait (DTG): Walk heel-to-toe in a straight line (3-5 meters) with hands crossed over chest; gaze fixed forward.

Delivery: In-person, supervised by a trained physical thera
Brak interwencji: General Health Advice
Participants in this arm receive no active intervention (no dynamic balance training or dual-task exercises). They are provided with general health advice and educational brochures about fall prevention and physical activity, but no structured exercise program is prescribed. They are asked to maintain their usual daily activities and are followed up at the same time points as the intervention groups.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Balance check 636
Ramy czasowe: baseline and at 6 weeks post-treatment
baseline and at 6 weeks post-treatment
PERCEIVED SRESS SCALE
Ramy czasowe: baseline and at 6 weeks post-treatment
The Perceived Stress Scale (PSS-10) is a 10-item self-report questionnaire designed to measure the degree to which situations in one's life over the past month are appraised as stressful. Items assess feelings of unpredictability, uncontrollability, and overload (e.g., "How often have you felt nervous and stressed?"). Responses are rated on a 5-point Likert scale from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicating higher perceived stress.
baseline and at 6 weeks post-treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Kafrelsheikh University

Śledczy

  • Główny śledczy: MAHMOUD EWIDA, PROFESSOR, Kafr Elsheikh University, Faculty of Physical Therapy, Egypt

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 maja 2027

Ukończenie studiów (Szacowany)

1 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

24 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

6 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • Effect of Exercises on stress

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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