- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07671807
Adapted Table Tennis for Disabilities
Health Promotion Through Adapted Table Tennis for Individuals With Disabilities
Přehled studie
Detailní popis
In recent decades, the participation of individuals with disabilities in sports has gradually increased, closely associated with medical advancements, growing societal emphasis on physical well-being, and the expansion of exercise opportunities. According to statistics from the United States Census Bureau, there were approximately 85 million people with disabilities in 2014; however, only around 2 million of them participated in recreational or competitive sports. Despite the growing availability of sports opportunities, about 60% of individuals with disabilities still do not engage in regular physical activity. This indicates the presence of multiple barriers to participation, such as limited awareness about the benefits of exercise and inadequate accessibility of sports facilities.
The International Paralympic Committee (IPC) and various National Governing Bodies (NGBs) have played a crucial role in promoting sports participation among individuals with disabilities by establishing institutionalized competition and training systems that foster the development of sports culture. For example, the number of athletes participating in the Paralympic Games has grown from 400 at the 1960 Rome Paralympics to 4,200 at the 2012 London Paralympics. The 2024 Paris Paralympic Games are expected to host 4,400 athletes, reflecting the rapid growth and increasing recognition of disability sports. This growth not only represents society's greater acceptance of para-sports but also underscores the demand among individuals with disabilities for participation and the potential health benefits associated with such involvement.
The health benefits of physical activity for individuals with disabilities are well-supported by a growing body of research. Exercise has been shown to improve endurance, muscular strength, cardiopulmonary function, and flexibility. It also enhances balance and motor skills. Moreover, physical activity provides significant psychological benefits, including improved self-esteem, body image, self-awareness, and emotional regulation. From a cardiovascular perspective, athletes with disabilities tend to have higher levels of high-density lipoprotein (HDL) cholesterol, lower smoking rates, and a reduced risk of cardiovascular disease. Specific populations, such as individuals with amputations or spinal cord injuries, also benefit from physical activity through improved proprioception, reduced hospitalization rates, lower incidence of pressure ulcers, and decreased infection risk.
Nevertheless, current research on the health benefits of adapted table tennis for individuals with disabilities remains relatively limited. Due to its technical versatility, high adaptability, and low facility requirements, table tennis has emerged as a suitable exercise option for this population. This study will implement a 12-week table tennis training program to assess its impact on the physical and mental health of individuals with disabilities and further evaluate whether this form of exercise can serve as an effective strategy for promoting their overall well-being.
The findings of this study aim to fill the existing research gap regarding the effects of adapted table tennis on individuals with disabilities and provide an empirical foundation for future exercise intervention programs, thereby advancing the promotion and development of regular physical activity among this population.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Chia-Ling Lee, MD
- Telefonní číslo: 886975357361
- E-mail: cathyleetw@gmail.com
Studijní místa
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Taiwan
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Kaohsiung City, Taiwan, Tchaj-wan, 807
- Nábor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kontakt:
- Chia-Ling Lee, MD
- Telefonní číslo: 886975357361
- E-mail: cathyleetw@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Individuals aged 18 to 75 years who hold a disability identification certificate issued by the Taiwan government and have been assessed by a physician and a professional coach as suitable for participating in adapted table tennis, with a willingness to take part in the study; Participants must respond "No" to all questions in the first section of the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+ 2024 edition) or, if they respond "Yes" to one or more questions in the first section, must respond "No" to all questions in the second section.
Exclusion Criteria:
- Individuals with uncontrolled cardiovascular diseases or relevant neurological history.
- Hearing impairment.
- Cognitive dysfunction.
- Individuals with uncontrolled psychiatric disorders who are unable to comply with the assessments.
- Individuals with color vision deficiencies or visual impairments.
- Pregnant women (self-reported).
- Individuals who have undergone lower limb musculoskeletal surgery or experienced musculoskeletal injuries within the past 6 months.
- Individuals with a history of significant head trauma.
- Individuals unable to comply with the testing schedule.
- Individuals advised by a physician to avoid moderate to high-intensity exercise or those deemed unsuitable for physical activity.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Adapted table tennis training group
The participants who engage in weekly 2-hour group table tennis sessions for 12 weeks.
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Under the guidance of a professional adapted sports coach, participants in the experimental group will engage in weekly 2-hour group table tennis sessions for 12 weeks.
The sessions will include warm-up exercises, basic table tennis techniques, skill practice, and cool-down stretching exercises.
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Žádný zásah: Control group
The participants who only receive regular medical management without exercise training
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Muscle strength
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Static grip strength test
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Volume of Forced Vital Capacity (FVC) in Liters
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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FVC is the total volume of air that can be forcefully and completely exhaled after a full inspiration.
It is measured in liters (L) using a digital spirometer.
Higher values indicate greater lung volume and better respiratory capacity.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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6-Minute Walk/Push Test (6MWPT) Distance
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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This outcome measures the maximal distance a participant can travel in 6 minutes on a hard, flat surface.
Depending on the participant's ambulatory ability, this was conducted either by walking (6-Minute Walk Test) or by propelling a manual wheelchair (6-Minute Push Test).
The total distance is recorded in meters (m).
Higher values indicate better cardiopulmonary endurance and functional mobility.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Flexibility
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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chair sit-and-reach test
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Waist Circumference in Centimeters
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Waist circumference will be measured using a flexible, non-stretchable anthropometric tape.
The measurement is taken at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest (or at the level of the umbilicus, depending on your exact protocol).
The data will be reported as a continuous variable in centimeters (cm).
This measurement serves as an indicator of central adiposity and body composition changes.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Total Score on the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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The GAD-7 is a self-administered questionnaire used to assess the severity of generalized anxiety disorder symptoms.
It consists of 7 items, with each item scored from 0 (not at all) to 3 (nearly every day).
The total aggregated score ranges from 0 to 21.
Higher scores indicate greater severity of anxiety symptoms (Score guidelines: 0-4 minimal, 5-9 mild, 10-14 moderate, 15-21 severe anxiety).
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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Bone Mineral Density (BMD) Assessed by Dual-Energy X-ray Absorptiometry in g/cm^2
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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Bone mineral density of the whole body (or specific regions such as lumbar spine and femoral neck) will be measured using Dual-Energy X-ray Absorptiometry (DXA).
The outcome is reported in grams per square centimeter (g/cm^2).
Higher values indicate stronger, denser bones and a lower risk of osteopenia or osteoporosis.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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Number of Participants with Abnormal Blood Laboratory Values
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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A comprehensive blood panel will be drawn to evaluate general health and physiological safety.
The panel includes metabolic markers (HbA1C), lipid profile (Total cholesterol, Triglycerides, HDL, LDL), renal function and electrolytes (BUN, Cr, uric acid, Na, K, Ca, Mg), liver enzymes (GPT, GOT), complete blood count (CBC), albumin, CRP, and Vitamin D. The outcome is reported as the total number of participants exhibiting clinically significant abnormal values outside the standard laboratory reference ranges.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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Volume of Forced Expiratory Volume in 1 Second (FEV1) in Liters
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
It is measured in liters (L) using a digital spirometer.
Higher values indicate better pulmonary function and airway patency.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Ratio of FEV1 to FVC (FEV1/FVC)
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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This outcome calculates the ratio of Forced Expiratory Volume in 1 Second (FEV1) to Forced Vital Capacity (FVC).
It is expressed as a percentage (%).
It serves as a clinical indicator of airway obstruction, with higher values generally indicating better respiratory mechanics.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Total Lean Body Mass Assessed by Dual-Energy X-ray Absorptiometry (in kg)
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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Total body lean mass (which includes muscle mass and excludes fat and bone mineral content) will be measured using Dual-Energy X-ray Absorptiometry (DXA).
The outcome is reported in kilograms (kg).
Higher values indicate greater muscle mass, reflecting positive structural adaptations to the adapted sports intervention.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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Percentage of Total Body Fat Assessed by Dual-Energy X-ray Absorptiometry
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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Total body fat percentage will be measured using Dual-Energy X-ray Absorptiometry (DXA).
The outcome is calculated as fat mass divided by total body mass and reported as a percentage (%).
This metric is used to evaluate changes in body composition and metabolic health.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Sensory, Motor, and F-wave Latencies of the Median and Ulnar Nerves (in ms)
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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This outcome measures the electrophysiological latencies of the bilateral median and ulnar nerves using nerve conduction studies.
The parameters include sensory nerve action potential (SNAP) latency, distal motor latency (DML), and minimum F-wave latency.
All latency measurements are recorded and reported in milliseconds (ms).
Prolonged latencies serve as objective indicators of focal nerve entrapment (such as carpal or cubital tunnel syndrome) or proximal conduction delays.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Sensory and Motor Nerve Conduction Velocities of the Median and Ulnar Nerves (in m/s)
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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This outcome measures both the sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (MNCV) of the bilateral median and ulnar nerves using nerve conduction studies.
All velocities are recorded and reported in meters per second (m/s).
A decrease in conduction velocity may indicate potential nerve demyelination or early nerve compression associated with wheelchair use or adapted sports.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Number of Participants with Upper Limb Neuropathy (Median or Ulnar)
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Upper limb nerve conduction studies (NCS) will be performed to assess the presence of median neuropathy (e.g., carpal tunnel syndrome) or ulnar neuropathy.
The outcome is reported as the total number of participants diagnosed with either pathology based on abnormal electrophysiological findings.
This evaluates the neurological safety associated with the wheelchair/adapted sports intervention.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Number of Participants with Ultrasound-Detected Rotator Cuff Tears
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Musculoskeletal ultrasound of the bilateral shoulders will be performed to assess the presence or absence of rotator cuff tears (full-thickness or partial-thickness).
The outcome is reported as the total number of participants exhibiting this pathology.
This parameter serves to evaluate the musculoskeletal safety and potential overuse injury associated with the intervention.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Number of Participants with Ultrasound-Detected De Quervain's Tenosynovitis
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Musculoskeletal ultrasound of the bilateral wrists will be performed to assess the presence or absence of De Quervain's tenosynovitis (inflammation of the abductor pollicis longus and extensor pollicis brevis tendons).
The outcome is reported as the total number of participants presenting with this pathology.
This parameter serves to evaluate the musculoskeletal safety of the intervention.
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Compound Muscle Action Potential (CMAP) Amplitude of the Median and Ulnar Nerves (in mV)
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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The baseline-to-peak amplitude of the compound muscle action potential for bilateral median and ulnar nerves, measured in millivolts (mV).
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Sensory Nerve Action Potential (SNAP) Amplitude of the Median and Ulnar Nerves
Časové okno: Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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The baseline-to-peak amplitude of the sensory nerve action potential for bilateral median and ulnar nerves, measured in microvolts
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Pre-intervention (T0), after 12 weeks of intervention (T1), and 6 months after intervention (T2).
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Chia-Ling Lee, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital, Physical and Rehabilitation Medicine Department
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
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
Klíčová slova
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