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Stress Modulation and Dynamic Balance

29 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

72

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Altro: 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
Sperimentale: 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
Altro: 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
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Balance check 636
Lasso di tempo: baseline and at 6 weeks post-treatment
baseline and at 6 weeks post-treatment
PERCEIVED SRESS SCALE
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Kafrelsheikh University

Investigatori

  • Investigatore principale: MAHMOUD EWIDA, PROFESSOR, Kafr Elsheikh University, Faculty of Physical Therapy, Egypt

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

1 luglio 2027

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Effect of Exercises on stress

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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