- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01759342
Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation
The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis
Visão geral do estudo
Status
Condições
Descrição detalhada
This protocol was designed to assess if when subjects with CF are admitted to the hospital for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity aerobic, resistance, flexibility and balance exercises) was superior to our "usual care intervention (30 min/day of self selected mode and intensity of exercise) in improving aerobic capacity, muscle strength/power, flexibility and balance.
The experimental group will participate in the following regime:
Day 1 - Evaluation including standardized tests and measures: If Day 1 is a M,W, F, day 2 will constitute: aerobic exercise between 20-30 minutes based on patient tolerance using the appropriate RPE scale (13-15 on Borg with patients ages 13-21, and 6-8 on pictoral CERT with patients ages 6-12)to ensure correct intensity. Choices will include treadmill, stationary bike, game bike, or ambulating at varying intensities throughout hospital; Balance Activities: Standing on bosu ball while performing UE activity (throwing, catching with another ball, Frisbee, etc.). Standing on one leg or B LE's will be determined by patients currently level.
If Day 1 is a Tuesday or Thursday, day 2 will constitute: 5-10 minutes of aerobic activity at warm up level (11-13 on Borg, and 4-6 on PCERT)x resistance training for UE: biceps, triceps, lattisimus, rhomboids/mid-trap, thoracic expansion exercises, and other muscles based on patient needs; resistance training for LE: quadriceps, hamstrings, gluteals (especially maximus and medius), and other muscles depending on patient need, core and abdominal strengthening, Stretches for flexibility depending on the patients individual needs: Thoracic expansion stretches will be done with every pt. supine and sidelying. Stretches are held for 10 seconds and repeated 10 times, Hamstring stretches will be performed if pt unable to reach line with sit and reach test.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmimgham
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- age 6 to 21 years
- admission for an acute Cystic fibrosis (CF) exacerbation
- forced expiratory volume in 1 s (FEV1) of < 60% of predicted at admission
Exclusion Criteria:
- medically unstable as deemed by the attending physician
- had completed both arms of the present study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Comprehensive exercise program
Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
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Comparador Ativo: Usual care exercise
30 minutes/day of self selected mode and intensity of aerobic exercise
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Aerobic capacity following intervention of a comprehensive excercise training program
Prazo: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Muscle strength and power following intervention of a comprehensive excercise training program
Prazo: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
|
Assessed with arm curl test, partial curl up test, timed 10 repetition sit to stand test
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Posture/flexibility following intervention of a comprehensive excercise training program
Prazo: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Assessed with humeral distance, shoulder flexion range of motion, and hamstring length
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Balance following intervention of a comprehensive excercise training program
Prazo: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Assessed with the pediatric Berg balance scale
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: John D Lowman, PT, PhD, University of Alabama at Birmingham
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- 12.21.2012
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