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- Ensaio Clínico NCT02781233
A Progressive Resistance Training Program in Patients With Haemophilia
The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Valencia, Espanha, 46010
- University of Valencia
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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:
- diagnosis of haemophilia A or B
- willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations
- approval by their hematologist to participate in the exercise program
- age between 18 and 60 years
- informed consent signed.
Exclusion Criteria:
- the inability to attend exercise sessions at least twice a week for 6 consecutive weeks
- non adherence to instruction on proper exercise technique
- surgical procedures performed 6 weeks prior to or during the exercise program
- participation in any other form of exercise, including rehabilitation, during the study; (5) changes in medication during the study
- a major bleeding episode that posed a risk or prevented exercise
- History of FVIII inhibitor (titer ≥ 0.6 BU [Bethesda unit]) or detectable FVIII inhibitors at screening (titer ≥ 0.4 BU)
- Another haemostatic defect
- Need for major surgery
- Withdrawal of informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Training group
Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions.
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Progressive resistance training program
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Comparador de Placebo: Control group
Usual daily activities
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Usual daily activities
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Muscle strength
Prazo: baseline and 8 weeks
|
For measuring the isometric knee flexion and extension, ankle plantarflexion and dorsiflexion strength and isometric elbow flexion and extension strength, a portable hand-held dynamometer will be used (Nicholas Manual Muscle Tester, Lafayette Instruments, Indiana, USA).
|
baseline and 8 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Timed Up and Go
Prazo: baseline and 8 weeks
|
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. |
baseline and 8 weeks
|
|
Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )
Prazo: baseline and 8 weeks
|
The Haemophilia-QoL questionnaire is a self-report modular instrument that assesses nine relevant HRQoL domains for patients with haemophilia (e.g.
physical health, daily activities, joint damage, pain, treatment satisfaction, treatment difficulties, emotional functioning, mental health, relationships and social activity).
|
baseline and 8 weeks
|
|
Change in Bleedings
Prazo: daily (during the 8 weeks of intervention)
|
Number of Bleedings During the study
|
daily (during the 8 weeks of intervention)
|
|
Change in viscoelastic properties (rectus femoris)
Prazo: baseline and 8 weeks
|
Myoton Pro
|
baseline and 8 weeks
|
|
Change in sit-to-stand test
Prazo: baseline and 8 weeks
|
The time taken for the participant to stand up and sit down from a standard 45 cm chair with arms three times, as quickly as possible, was measured.
|
baseline and 8 weeks
|
|
Change in Haemophilia Activities List questionnaire
Prazo: baseline and 8 weeks
|
The Haemophilia Activities List questionnaire measures the impact of hemophilia on self-perceived functional abilities in adults. It contains 42 multiple choice questions in seven domains: Lying/sitting/kneeling/standing (8 items) Functions of the legs (9 items) Functions of the arms (4 items) Use of transportation (3 items) Self-care (5 items) Household tasks (6 items) Leisure activities and sports (7 items) The most important outcomes are the overall sum score and three component scores relating to upper extremity activities, basic lower extremity activities, and complex lower extremity activities. A domain score for each of the seven domains can also be calculated. |
baseline and 8 weeks
|
|
Change in The Haemophilia Joint Health Score (HJHS)
Prazo: baseline and 8 weeks
|
The HJHS measures joint health, in the domain of body structure and function (i.e.
impairment), of the joints most commonly affected by bleeding in hemophilia: the knees, ankles, and elbows.The HJHS 2.1 provides a total score (higher score is worse; max=124), joint specific scores, and a global gait score.
|
baseline and 8 weeks
|
|
Change in Pain
Prazo: baseline and 8 weeks
|
11-point numerical pain rating scale with higher score meaning higher pain
|
baseline and 8 weeks
|
|
Change in workability index
Prazo: baseline and 8 weeks
|
workability index with single question
|
baseline and 8 weeks
|
|
Change in analgesics use (days/week)
Prazo: baseline and 8 weeks
|
The number of days the participants used analgesics during the last week
|
baseline and 8 weeks
|
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Change in Range Of Motion (ROM)
Prazo: baseline and 8 weeks
|
elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer
|
baseline and 8 weeks
|
|
Change in Kinesiophobia
Prazo: baseline and 8 weeks
|
Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement
|
baseline and 8 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Felipe Querol-Fuentes, MD, PhD, University of Valencia
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H15-29504
Plano para dados de participantes individuais (IPD)
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Informações sobre medicamentos e dispositivos, documentos de estudo
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