- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07860541
Line Dancing With Blood Flow Restriction for Balance and Gait of Older Women (In-Person vs Online)
Fall Risk and Fatiguability Following Community Line Dancing Classes for Older Women
Falls are a leading cause of injury-related hospitalization among older women. Age-related declines in gait speed and postural stability are known risk-factors for falls. While exercise is well-known to help maintain or improve these losses, only 24.4% of older Canadian women are considered physically active.
Dance can act as a fun and social way to engage older women in exercise. Line dancing in particular has been shown to improve gait speed, knee extensor strength and endurance; however high doses are needed to achieve gains. Clifford and colleagues found that program lengths of 24 hours are needed to effect change, while Merome and colleagues recommend 3 hours per week. These high training doses may not be feasible for participants or community centres who offer programming. The time to commute to classes, find parking and caregiver roles at home are all cited as barriers to physical activity. We also propose that BFR could be a novel addition to increase the physiologic strain of online dance classes, which we hypothesize have a lower intensity and thereby lead to less fitness adaptations. Online classes are of interest as they can serve to reduce barriers to physical activity often experienced by older adults in Canada.
- We propose online dance classes have reduced efficacy in stimulating adaptations to gait speed, strength and endurance when compared to in-person classes.
- We propose blood flow restriction (BFR) as a novel addition to dance classes in order to aid in reaching physiological overload in more efficient time-frame.
BFR works by partially reducing blood flowing in and out of working muscles, thereby reducing oxygen availability, promoting anaerobic energy pathways and keeping metabolites in the muscles for a longer time period. Numerous studies have confirmed that when combined with low-intensity exercise BFR is capable of producing similar strength gains as high-intensity exercise. Additionally, BFR is safe and has been widely used among older adults and individuals with various medical conditions, including cardiovascular conditions.
While the benefits of BFR for muscle strength and hypertrophy have been greatly studied, there is limited research on its effects on gait and postural stability. Additionally, there is minimal research on potential combinations of BFR with dance-based activity.
- This study will examine the differences between online and in-person delivery of 90 minute line dance classes on the postural stability and gait of older females over 10-weeks.
- This study will then investigate the effects of combining BFR with 10-weeks of 90 minute line dancing classes for the postural stability and gait of older females.
Finally, muscle oxygenation and kinematic analysis will be conducted to help provide insight into any potential changes in gait and postural stability.
The intervention will consist of 10-weeks of line dancing classes, during which half the groups will be randomized to wear elasticized BFR bands pulled tight to a 7/10 of perceived pressure. Classes will be once per week for 90 minutes and will include a warm-up, 4 pre-set choreographies and a cool down. Breaks will be provided throughout the class.
Assessments will occur at pre, mid and post.
Gait will be assessed during a 6-minute walk test. During the test, participants will be filmed from a sagittal view to obtain kinematics. They will also be asked to wear a heart-rate monitor and muscle oxygenation sensors on their lower limbs.
Postural stability will be assessed via 30-seconds of quiet standing on force plates in conditions of eyes open, eyes closed and foam. Participants will also be asked to wear an accelerometer on their upper back during the assessment to obtain correlation to force plate data.
Functional strength will be assessed using 30-second sit to stand (with a secondary timer to obtain 5 time sit to stand length) and the Calf-Raise Senior test. Dynamic balance and mobility will be evaluated using the Functional Reach Test, and the Timed Up and Go in both single and dual-tasks. Aerobic capacity will be measured using a 3 minute Step Test while the participant wears a heart-rate monitor and muscle oxygenation sensors.
Finally scales of fears of falling, social connectedness, and overall mental health will be collected.
It is expected that this study will have great practical implications as the accessibility of this program can provide opportunities to older adults from various remote locations to increase their levels of physical activity in a safe manner. The affordability may also aid in adoption by community health and recreation centers as an easy-to-implement program that helps to improve the postural stability and gait of older women, thereby promoting independence and quality of life.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Andreas Bergdahl
- Número de teléfono: 3372 514-848-2424
- Correo electrónico: andreas.bergdahl@concordia.ca
Ubicaciones de estudio
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Quebec
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Montreal, Quebec, Canadá, H3G 1M8
- Reclutamiento
- Concordia University
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Contacto:
- Andreas Bergdahl
- Número de teléfono: +3372 514-848-2424
- Correo electrónico: andreas.bergdahl@concordia.ca
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Investigador principal:
- Emma H Chen
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Sub-Investigador:
- Rudy Grief
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female
- Healthy older adults (60+ years old)
- Comprehension of spoken English
- Able to visit Concordia University for all testing sessions
- No contraindication for physical activity from their physician
- For online arm: Access to a device with a webcam, Zoom and stable internet
Exclusion Criteria:
- Occurrence/onset of a stroke, vertigo, concussion or lower-extremity injury during the 10-week intervention period
- Presence of venous thromboembolism, peripheral vascular disease or sickle cell anemia
- Vacations during the study period
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Online dance classes without BFR
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Participants will complete 10 weeks of beginner level line dancing classes, once per week for 90-minutes on Zoom. Classes are structured with a 10 minute warm-up that reviews basic line-dancing steps, 4 dances of choreography (32 counts that repeat throughout the whole song, no tags, primarily facing forward), followed by cool-down stretches. |
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Comparador activo: In-person dance classes without BFR
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Participants will complete 10 weeks of beginner level line dancing classes, once per week for 90-minutes at a local community centre. Classes will follow the same structure as the online program. |
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Experimental: Online dancing with BFR
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Participants will complete 10 weeks of beginner level line dancing classes, once per week for 90-minutes on Zoom. Classes are structured with a 10 minute warm-up that reviews basic line-dancing steps, 4 dances of choreography (32 counts that repeat throughout the whole song, no tags, primarily facing forward), followed by cool-down stretches. Participants in the BFR group will be asked to wear 5 centimetre elasticized BFR bands on their proximal thighs at a 7/10 of perceived tightness during the dance classes. |
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Experimental: In-person dancing with BFR
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Participants will complete 10 weeks of beginner level line dancing classes, once per week for 90-minutes at a local community centre. Classes will follow the same structure as the online program. Participants in the BFR group will be asked to wear 5 centimetre elasticized BFR bands on their proximal thighs at a 7/10 of perceived tightness during the dance classes. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gait Speed
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Changes in gait speed during a 6 Minute Walk Test reported as m/s. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Postural Stability
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Change postural stability during 30 second trials of quiet standing (conditions: eyes open, eyes closed, foam). Forceplate data will be processed according to recommendations by Quijoux and colleagues (2021) postural sway will be reported in cm. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Functional Strength - Sit to Stand
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Changes in repetitions on 30 second Sit-to-Stand. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Functional Strength - Calf Strength
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Changes repetitions on the Calf Raise Senior Test. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Aerobic Capacity - Muscle Oxygenation
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Changes in the slope, peaks and plateaus of participant's muscle oxygenation monitors during a 3 minute aerobic step test and 1 minute recovery period. The monitors will be worn on the participants gastrocnemius muscles and their vastus lateralis. Reported as %SmO2. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Gait - Muscle Oxygenation
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Changes in the slope, peaks and plateaus of participant's muscle oxygenation monitors during the 6 Minute Walk Test. The monitors will be worn on the participants gastrocnemius muscles and their vastus lateralis to gait insight into oxygen delivery and consumption during walking. Reported as %SmO2. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Aerobic Capacity - Heart Rate
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Changes in the slope, peaks and plateaus of participant's heart rate during a 3 minute aerobic step test and 1 minute recovery period. Participants will also be wearing muscle oxygenation monitors on their gastrocnemius muscles and on their vastus lateralis. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Gait - Heart Rate
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Changes in the slope, peaks and plateaus of participant's heart rate during the 6 Minute Walk Test. The monitors will be worn around the participant's chest while walking. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Gait - Kinematics
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Changes in participant's step length and cadence during the 6 Minute Walk Test will be reported. The parameters will come from a camera placed sagittally during the 6 Minute-Walk Test. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Mobility
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Participants will be asked to complete the Timed Up and Go test in 3 conditions (single task, cognitive dual-task counting backwards by 3s, mobility dual-task holding water). The time to do each will be reported. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Dynamic Balance
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Participants will be asked to complete a standing Functional Reach Test and the distance in cm will be recorded. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Survey - Number of Falls
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Participants will be asked to report any falls during the intervention period. The number of falls experienced will be reported. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Survey - Fear of Falls
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Participants will be asked to complete the Falls Efficacy Scale-International scale. Min score = 16, max score = 64. A higher score of 64 indicates a severe concern about falling. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Survey - Balance Confidence
Periodo de tiempo: Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Participants will be asked to complete the Activities-Specific Balance Confidence Scale. Min score = 0, Max score = 100. 100 indicates complete confidence in the ability to maintain balance. |
Comparing pre-testing (week 0) to mid-testing (week 5) and post-testing (week 10).
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Surveys - Social Participation
Periodo de tiempo: Comparing pre-testing (week 0) and post-testing (week 10).
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Participants will be asked to complete the Self-efficacy for Social Participation scale (12-item). A total score of 0 indicates not confident at all, while a maximum score of 36 indicates complete confidence. |
Comparing pre-testing (week 0) and post-testing (week 10).
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Surveys - Social Support
Periodo de tiempo: Comparing pre-testing (week 0) and post-testing (week 10).
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Participants will be asked to complete the Duke Social Support Index (11-item). Minimum score of 11 indicates low connectedness while a maximum of 33 indicates greater perceived social support. |
Comparing pre-testing (week 0) and post-testing (week 10).
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Surveys - Depression
Periodo de tiempo: Comparing pre-testing (week 0) and post-testing (week 10).
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Participants will be asked to complete the Geriatric Depression Scale: Short Form. Min score = 0, max score = 15. A higher score indicates greater likelihood of depression. |
Comparing pre-testing (week 0) and post-testing (week 10).
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Surveys - Anxiety
Periodo de tiempo: Comparing pre-testing (week 0) and post-testing (week 10).
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Participants will be asked to complete the Geriatric Anxiety Inventory. Min score = 0, Max score = 20. I higher score indicates greater feelings of worry or anxiety. |
Comparing pre-testing (week 0) and post-testing (week 10).
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Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- 30020985
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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