A Progressive Resistance Training Program in Patients With Haemophilia
15. oktober 2018 opdateret af: Felipe Querol Fuentes, University of Valencia
The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia
This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The training program aims improving muscular strength and endurance in the relevant muscles and joints (knee, elbow, ankle, shoulder and hip) in order to improve the quality of life in the patients.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Valencia, Spanien, 46010
- University of Valencia
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Placebo komparator: Control group
Usual daily activities
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Usual daily activities
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Muscle strength
Tidsramme: baseline and 8 weeks
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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).
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baseline and 8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Timed Up and Go
Tidsramme: 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
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Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )
Tidsramme: baseline and 8 weeks
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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).
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baseline and 8 weeks
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Change in Bleedings
Tidsramme: daily (during the 8 weeks of intervention)
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Number of Bleedings During the study
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daily (during the 8 weeks of intervention)
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Change in viscoelastic properties (rectus femoris)
Tidsramme: baseline and 8 weeks
|
Myoton Pro
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baseline and 8 weeks
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Change in sit-to-stand test
Tidsramme: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Change in Haemophilia Activities List questionnaire
Tidsramme: baseline and 8 weeks
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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
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Change in The Haemophilia Joint Health Score (HJHS)
Tidsramme: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Change in Pain
Tidsramme: baseline and 8 weeks
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11-point numerical pain rating scale with higher score meaning higher pain
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baseline and 8 weeks
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Change in workability index
Tidsramme: baseline and 8 weeks
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workability index with single question
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baseline and 8 weeks
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Change in analgesics use (days/week)
Tidsramme: baseline and 8 weeks
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The number of days the participants used analgesics during the last week
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baseline and 8 weeks
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Change in Range Of Motion (ROM)
Tidsramme: baseline and 8 weeks
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elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer
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baseline and 8 weeks
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Change in Kinesiophobia
Tidsramme: baseline and 8 weeks
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Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement
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baseline and 8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Felipe Querol-Fuentes, MD, PhD, University of Valencia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
24. oktober 2017
Primær færdiggørelse (Faktiske)
25. juni 2018
Studieafslutning (Faktiske)
25. juni 2018
Datoer for studieregistrering
Først indsendt
18. maj 2016
Først indsendt, der opfyldte QC-kriterier
20. maj 2016
Først opslået (Skøn)
24. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. oktober 2018
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H15-29504
Plan for individuelle deltagerdata (IPD)
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