- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07571369
Stress Modulation and Dynamic Balance
Impact of Dual Task Therapeutic Exercises on Stress Modulation and Dynamic Balance in University Students
Přehled studie
Detailní popis
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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: AMMAR GHALLAB, TEACHING ASSISTANT
- Telefonní číslo: 0201065825099
- E-mail: ammarsgh122017@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Dynamic Balance Training Only
Participants perform a structured set of dynamic balance exercises under single-task conditions (motor task only). Exercises include:
Delivery: In-person, supervised by a trained physical ther |
Participants perform a structured set of dynamic balance exercises under single-task conditions (motor task only). Exercises include:
Delivery: In-person, supervised by a trained physical thera |
|
Experimentální: 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:
Delivery: In-person, supervised by the same trained physical therapist as Arm A. Frequency & Duration: Twice weekly for 6 |
Participants perform a structured set of dynamic balance exercises under single-task conditions (motor task only). Exercises include:
Delivery: In-person, supervised by a trained physical thera |
|
Žádný zásah: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Balance check 636
Časové okno: baseline and at 6 weeks post-treatment
|
baseline and at 6 weeks post-treatment
|
|
|
PERCEIVED SRESS SCALE
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: MAHMOUD EWIDA, PROFESSOR, Kafr Elsheikh University, Faculty of Physical Therapy, Egypt
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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