- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07815470
Dancing as an Alternative to the Traditional Exercising in Older Adults With Cardiac Diseases (1382)
The Effectiveness of Azerbaijani National Dances on Cardiorespiratory Fitness and Quality of Life of Older Adults With Chronic Heart Failure Diagnosis
According to the Global Burden of Disease Study (2017) 64 million people worldwide are living with Heart Failure (HF). Risk factors of HF include age, history of coronary heart disease, atrial fibrillation, hypertension, diabetes mellitus, smoking and low physical activity.
There is clear evidence that regular physical activity can increase life expectancy and improve cognitive function, and delay functional disabilities associated with aging. Physical Activity and exercise training is considered as one of the components cardiovascular disease prevention and rehabilitation program. There is a growing scientific support that cardiac rehabilitation (CR) slows, stabilizes or regresses cardiovascular disease (CVD). In addition, it has been shown that CR programs significantly reduce re-hospitalisation and death from CVDs by up to 25%.
Despite of strong evidence of the positive effects of exercise training in Chronic HF patients, the adherence to the exercise component of CR is still not at the level recommended by the international physical activity guidelines. Patients participating in physical activity programs are faced with several obstacles, such as orthopaedic limitations to exercise, or being severely overweight. Another most common barriers for participating in CR are family and employment obligation, psychological well-being and age ("CR is only for adults"). Participation of older adults in physical exercises programs is highly influenced by their personal interest in activity type, engagement and perceived advantages. The author is also mentioned that engaging in different types of activities or adding new elements to the traditional exercises may increase and maintain individuals' interest and engagement in physical activity. This will improve their commitment t the regular exercise and leading to improved health outcomes.
World Health Organisation defines dance as a type of physical activity and recommends its implementation to develop physical skills, especially in the least active population groups. Scientists highlight the advantages of dancing over traditional strength and balance exercises that are often performed individually, whereas dance is predominantly a group activity.
According to the Ministry of Culture of the Republic Azerbaijan, Azerbaijani traditional dances represent the ancient culture of the country and are popular activity among both young and older people. Azerbaijani dancing has a major social role in bringing people together during celebration of National Holidays and family events.
However, use of traditional dancing in general, and Azerbaijani dances particularly, as an intervention in CR programs has not been well established. Screening of reports published since 2015, revealed only randomized control studies which identified the dance intervention as national/cultural dancing style. All those studies demonstrated positive impact of traditional dancing on the functional capacity and psychological condition of people with chronic diseases.
More research on the use of the cultural dancing as an alternative to traditional exercise programs as a part of CR could provide clearer evidence about the role and effectiveness of traditional dance in CR.
The aim of this research is to investigate the impact of Azerbaijani Cultural Dances on cardiorespiratory fitness and quality of life of patients with chronic HF.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Baku, Azerbaiyán, AZ1102
- Azerbaijan Sports Academy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Key Inclusion Criteria:
- Echocardiography detected ejection fraction - 40-49% to justify the heart failure
- Age between 65-85.
Exclusion Criteria:
- Age below 65
- Ejection fraction less than 40% and higher than 49%
- Structural changes of the myocardium (aneurysms, scars, valvular diseases).
- Signs of pleural or pericardial effusions
- Clinically manifested comorbidities (unstable angina)
- Uncontrolled Cardiac Arrhythmias
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Dancing arm. The intervention will last for 12 weeks, with a twice weekly session lasting 60 min.
Dance sessions will be delivered by the professional dance instructor who trained to work with older adults. Exercise session - by physiotherapist who is trained and has a bachelor's degree in Sport and Exercise Science. Considering that sessions are going to be conducted with one MD and one Nurse on site, 5-7 participants per each session are permitted for the easy observation and help in case of necessity. Only one dance/exercise instructor will attend the session. Certified MD and nurse will observe the whole session. They both BLS and AED application trained. There is an EAD on site. Lab staff is instructed about contact details of Ambulance and Emergency services. The nearest Ambulance station is in 3 minutes driving distance. Each dancing sessions will consist of three phases: 15 min warm-up, 30 min dance, 15 minutes cooldown period. According to the exercise recommendations in individuals with chronic heart failure, session will consist of aerobic /endurance exercises. |
Dance sessions will be delivered by the professional dance instructor who trained to work with older adults. Exercise session - by physiotherapist who is trained and has a bachelor's degree in Sport and Exercise Science. Considering that sessions are going to be conducted with one MD and one Nurse on site, 5-7 participants per each session are permitted for the easy observation and help in case of necessity. Only one dance/exercise instructor will attend the session. Certified MD and nurse will observe the whole session. They both BLS and AED application trained. There is an EAD on site. Each dancing and exercising sessions will consist of three phases: 15 min warm-up, 30 min dance/exercise session, 15 minutes cooldown period. Exercise sessions are going to be designed based on the 2020 ESC Guidelines on sports cardiology and exercise in pat |
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Comparador activo: Exercising Group
Exercise sessions are going to be designed based on the 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. According to the exercise recommendations in individuals with chronic heart failure, session will consist of aerobic /endurance exercises with low intensity about 40% of VO2 peak. This will continue for about 2 weeks. After 2 weeks the intensity will be gradually increased to 50-65% if tolerated with aiming to reach 70-75% by the end of the 12th week. In addition to the aerobic/endurance training, resistance training exercises will also be added to the structure of the sessions (the intensity level will be kept the same as with aerobic). Warm-up is going to start with very low intensity aerobic/endurance training. Cool-down is stretching exercises and respiratory exercises (10-15 minutes). Before and after each session blood pressure, resting HR and oxygen saturation will be measured. |
Exercise sessions are going to be designed based on the 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. According to the exercise recommendations in individuals with chronic heart failure, session will consist of aerobic/endurance exercises with low intensity about 40% of VO2 peak. This will continue for about 2 weeks. After 2 weeks the intensity will be gradually increased to 50-65% if tolerated with aiming to reach 70-75% by the end of the 12th week. In addition to the aerobic/endurance training, resistance training exercises will also be added to the structure of the sessions (the intensity level will be kept the same as with aerobic). Warm-up is going to start with very low intensity aerobic/endurance training. Cool-down is stretching exercises and respiratory exercises (10-15 minutes). Before and after each session blood pressure, resting HR and oxygen saturation will be measured. |
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Sin intervención: Control Group
Control group participants will be asked to maintain their normal lifestyle during the 12-week period, including physical activity and social interaction patterns.
Participants in the control group will undergo the same pre- and post intervention procedures at T-0 and T- 12.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cardiorespiratory fitness
Periodo de tiempo: Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.
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Maximal Oxygen Capacity (VO2 max) is consiedered a gold standard in measuring cardiorespiratory fitness.
Cardiopulmonary exercise testing will be conducted to all participants to measure cardiorespiratory fitness.
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Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.
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Quality of Life assessment
Periodo de tiempo: Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.
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Quality of life (QoL) is one of the factors that is highly impacted in the older adult population and defined as individuals' perception of their position in life in relation to their goals, expectations, standards, and concerns.
Research shows that chronic heart failure (CHF) patients experience depression and sleeping disorders, resulting in poor QoL.
The QoL will be measured with The Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Minimum value for this scale is 0 and maximum value is 105.
The lower the score the better the outcome.
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Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Muscle Strength
Periodo de tiempo: Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.
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All participnats will go through muscle strength measurements using hand-held dynamometers.
Hand grip strength (HGS), measured with a hand-held dynamometer, is suggested as a new clinical vital sign and is recommended for use as a measurement to identify older adults at risk of poor health status.
Low HGS is associated with higher rates of hospitalization, mortality, and low QoL.
HGS is also identified as a physical, behavioural, and psychological factor and is proposed as a health status indicator.
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Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.
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Fall Risk Assessment
Periodo de tiempo: Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.
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Fall risk will be assessed on Biodex Balance machine.
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Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LMS REC - 2025-1382
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Participants personal data includes full name, date of birth, age and gender, contact details and health information. This personal information will be coded and anonymised after the intervention phase of the study.
The collected anonymised data will be deleted 7 years after the publication of the results in academic sources.
The data will be available to be used for additional and subsequent research purposes within the 7 years period.
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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