- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07680712
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Comparative Effects of Yoga Versus Stretching-Strengthening Exercises on Physical Fitness in Sedentary Young Adults
The goal of this clinical trial is to learn if yoga or stretching-strengthening exercises are more effective in sedentary young adults who are currently healthy but at risk due to inactivity. The main questions it aims to answer are:
Which exercise type leads to better improvements in physical fitness, mental well-being, and sleep quality based on a person's starting profile?
How do initial levels of balance and muscle strength affect how well a person responds to these exercises?
Researchers will compare a yoga group to a stretching-strengthening exercise group to see if one approach is more effective than the other for specific types of individuals.
Participants will:
Be evaluated for their starting physical fitness (balance and strength) and psychological health.
Perform either yoga or stretching-strengthening exercises regularly during the study period.
Complete surveys about their mood, stress levels, and sleep quality.
Be re-tested at the end of the program to measure changes and improvements.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Sedentary lifestyle has become increasingly prevalent among young adults, leading to decreased physical fitness levels and negatively affecting psychological well-being. Although exercise-based interventions are widely recognized as effective strategies to mitigate these risks, there is limited comparative evidence regarding the differential effects of distinct exercise paradigms in healthy sedentary young individuals.
Yoga, as a mind-body intervention, integrates physical postures, breathing techniques, and mindfulness practices, and has been shown to improve flexibility, balance, muscular endurance, and psychological outcomes such as stress and well-being. On the other hand, traditional exercise programs focusing on stretching and strengthening target musculoskeletal functions more directly and are known to enhance muscle strength, endurance, and functional performance. However, studies directly comparing these two approaches under equivalent conditions (i.e., duration, frequency, and intensity) in a young, healthy sedentary population are scarce.
The primary aim of this randomized controlled trial is to compare the effects of a structured yoga program and a combined stretching and strengthening exercise program on physical fitness and psychological well-being in sedentary young adults. Additionally, the study aims to investigate how baseline physical and psychosocial profiles influence individual responses to these exercise interventions.
The study is designed as a two-arm, parallel-group randomized controlled trial. A total of 50 healthy sedentary individuals aged 18-30 years will be recruited and randomly assigned to either the yoga group or the stretching-strengthening exercise group. Both interventions will be conducted over a 6-week period, with sessions held twice per week, each lasting approximately 50 minutes.
The yoga intervention will consist of three main components: (1) breathing awareness and preparation, including pranayama and low-intensity mobility exercises; (2) a structured sequence of yoga postures (asanas) involving standing poses, balance poses, forward bends, backbends, and core stabilization exercises; and (3) a relaxation and mindfulness phase, including Savasana. The program will follow a progressive structure, gradually increasing intensity and complexity over the 6-week period.
The stretching-strengthening program will include core stabilization exercises, upper and lower extremity strengthening, and flexibility exercises. Exercises will target major muscle groups using body weight, resistance bands, and free weights, with progressive increases in repetitions, sets, and resistance. Each session will conclude with static and dynamic stretching exercises.
Outcome measures will be assessed at baseline and after the 6-week intervention period. Physical fitness parameters will include muscle strength (hand-held dynamometry), muscular endurance (sit-up test and plank duration), flexibility (sit-and-reach test), and dynamic balance (Y-Balance Test). Psychological outcomes will include psychological well-being and sleep quality, assessed using validated questionnaires. Additionally, participants' expectations regarding the intervention and their adherence and satisfaction levels will be evaluated.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sezen Karaborklu Argut Assistant Professor, PhD
- Número de telefone: +90 212 866 37 00
- E-mail: s.karaborkluargut@iuc.edu.tr
Locais de estudo
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Büyükçekmece
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Istanbul, Büyükçekmece, Turquia (Türkiye), 34500
- Istanbul University- Cerrahpasa
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Being between 18 and 30 years of age,
- Having a body mass index (BMI) of less than 30 kg/m²,
- Being healthy (having no known systemic, neurological, psychological, or orthopedic diseases),
- Not having participated in regular exercise within the last six months,
- Having a sedentary lifestyle according to the World Health Organization (WHO) definition (not performing at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic activity per week),
- Agreeing not to participate regularly in any other physical activity or exercise program for the duration of the study,
- Voluntarily participating in the study and agreeing to sign the written and verbal informed consent form in accordance with the principles of the Declaration of Helsinki.
Exclusion Criteria:
- Individuals with a history of injury, surgery, or pain complaints affecting the musculoskeletal system within the last six months,
- Individuals with neurological, cardiovascular, respiratory, endocrine, psychiatric, or metabolic diseases,
- Individuals who participate in any regular sporting activity,
- Female participants who are pregnant or have a suspected pregnancy,
- Individuals who state that they will not be able to participate regularly in the exercise program or will not be able to complete the study,
- Individuals who do not provide written and verbal informed consent to participate in the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Yoga group
6-week structured yoga program (50 min, 2 days/week).
|
The yoga group will participate in a structured beginner-level yoga program consisting of two 50-minute sessions per week for six weeks. All sessions will be conducted under the supervision of the researchers. Each session will comprise three primary phases: Preparation and Breath Awareness: 5 minutes Asana Flow: 40 minutes Deep Relaxation and Mindfulness: 5 minutes Throughout the intervention, the exercise intensity and difficulty level will be increased progressively. |
|
Experimental: Stretching -Strengthening Group
6-week core and extremity exercise program (50 min, 2 days/week)
|
The stretching-strengthening group will participate in a structured exercise program consisting of two 50-minute sessions per week for six weeks. The exercises will be performed under the supervision of the researchers. The program will comprise core stabilization, upper and lower extremity strengthening, and stretching phases. Throughout the intervention, the exercise intensity and difficulty level will be increased progressively; progression to the next level will occur when a participant can exceed the target number of repetitions without compromising proper form. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Muscle Strength
Prazo: Baseline
|
Measured by Hand-Held Dynamometer (HHD) for deltoid, biceps, triceps, quadriceps, hamstring, and gluteal muscles.
Highest value of 3 trials (kg/N)
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Baseline
|
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Core Endurance by Plank Test duration
Prazo: Baseline
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Measured by Plank Test duration (seconds) following ACSM protocols.
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Baseline
|
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Core Endurance by Sit-up Test
Prazo: Baseline
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Measured by Sit-up Test (repetitions in 1 minute) following ACSM protocols.
|
Baseline
|
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Flexibility
Prazo: Baseline
|
Measured by the Sit and Reach test to evaluate hamstring and lower back flexibility (in centimeters).
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Baseline
|
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Balance
Prazo: Baseline
|
Measured by Y-Balance Test composite score (%) in anterior, posteromedial, and posterolateral directions.
|
Baseline
|
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Muscle Strength
Prazo: At the end of 6 weeks.
|
Measured by Hand-Held Dynamometer (HHD) for deltoid, biceps, triceps, quadriceps, hamstring, and gluteal muscles.
Highest value of 3 trials (kg/N)
|
At the end of 6 weeks.
|
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Core Endurance by Plank Test duration
Prazo: At the end of 6 weeks.
|
Measured by Plank Test duration (seconds) following ACSM protocols.
|
At the end of 6 weeks.
|
|
Core Endurance by Sit-up Test
Prazo: At the end of 6 weeks.
|
Measured by Sit-up Test (repetitions in 1 minute) following ACSM protocols.
|
At the end of 6 weeks.
|
|
Flexibility
Prazo: At the end of 6 weeks.
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Measured by the Sit and Reach test to evaluate hamstring and lower back flexibility (in centimeters).
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At the end of 6 weeks.
|
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Balance
Prazo: At the end of 6 weeks.
|
Measured by Y-Balance Test composite score (%) in anterior, posteromedial, and posterolateral directions.
|
At the end of 6 weeks.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Psychological Well-being Score
Prazo: Baseline
|
Assessed using the Psychological Well-being Scale (validated in Turkish by Akın, 2008).
This is a multi-dimensional self-report scale that evaluates life satisfaction, self-acceptance, purpose in life, and personal growth.
The total score is calculated based on the sum of the sub-dimension scores.
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Baseline
|
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Sleep Quality
Prazo: Baseline
|
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a self-report scale used to assess the sleep quality of individuals over the past month.
Global scores range from 0 to 21, where higher scores indicate poorer sleep quality.
A total score of 5 or higher is considered indicative of poor sleep quality.
|
Baseline
|
|
Psychological Well-being Score
Prazo: At the end of the 6-week intervention.
|
Assessed using the Psychological Well-being Scale (validated in Turkish by Akın, 2008).
This is a multi-dimensional self-report scale that evaluates life satisfaction, self-acceptance, purpose in life, and personal growth.
The total score is calculated based on the sum of the sub-dimension scores.
|
At the end of the 6-week intervention.
|
|
Sleep Quality
Prazo: At the end of the 6-weeks
|
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a self-report scale used to assess the sleep quality of individuals over the past month.
Global scores range from 0 to 21, where higher scores indicate poorer sleep quality.
A total score of 5 or higher is considered indicative of poor sleep quality.
|
At the end of the 6-weeks
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
- there is contemporary evidence that high-intensity resistance exercises reduce levels of stress, anxiety, and depression.
- Stretching exercises have been reported to increase the range of motion (ROM) and may reduce the risk of musculoskeletal injuries when performed regularly.
- yoga may be as effective as or better than exercise at improving a variety of health-related outcome measures.
- yoga practices reduce stress, anxiety, depression, and chronic pain, improve sleep patterns, and enhance overall well-being and quality of life.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025/705
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