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Exercise Program to Improve Balance in Hemophilic Patients

10. Januar 2020 aktualisiert von: Felipe Querol Fuentes, University of Valencia

Effectiveness of an Exercise Program to Improve Balance and Dual Task in Hemophilic Patients. Clinical Trial

This study evaluates the effectiveness of a program of physiotherapy exercises to train the balance and dual task in adults patients with hemophilia

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The objective of the study is to create an exercise program to improve the static and dynamic balance in hemophilic patient. In addition, the effect of the exercise program on dual task, functionality, proprioception, QoL, risk of falls and the kinesiophobia will be analyzed.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

25

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Spanien
      • Valencia, Spanien, 46010
        • University of Valencia

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

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
  • With hemostatic coverage supervised by your hematologist.
  • Age between 18 and 60 years
  • Informed consent signed.

Exclusion Criteria:

  • Non adherence to instruction on proper exercise technique
  • Surgical procedures performed 6 months prior to or during the exercise program
  • A major bleeding episode that posed a risk or prevented exercise
  • Need for major surgery
  • Suffer from dizziness
  • Withdrawal of informed consent
  • Acquired hemophilia

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Control group
Usual daily activities
Sonstiges: Normal daily activities
Usual daily activities
Experimental: Training group
Each subject will participate in 2 sessions each week during 3 months.
Sonstiges: Progressive balance training
Progressive balance training program

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change of postural balance: amplitude of Center of Pressure (CoP) displacements
Zeitfenster: baseline and 3 months
Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system. Higher displacements indicate worse balance.
baseline and 3 months
Change of postural balance: velocity of Center of Pressure (CoP) displacements
Zeitfenster: baseline and 3 months
Velocity of CoP displacements will be assessed in millimeters using a computerized balance system. Higher velocity indicate worse balance.
baseline and 3 months
Change of postural balance: sway area of Center of Pressure (CoP) displacements
Zeitfenster: baseline and 3 months
Sway area of CoP displacements will be assessed in mm^2 using a computerized balance system. Higher sway area indicate worse balance.
baseline and 3 months
Change of dual task balance: amplitude of Center of Pressure (CoP) displacements
Zeitfenster: baseline and 3 months
Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher displacements indicate worse balance.
baseline and 3 months
Change of dual task balance: velocity of Center of Pressure (CoP) displacements
Zeitfenster: baseline and 3 months
Velocity of CoP displacements will be assessed in millimeters using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher velocity indicate worse balance.
baseline and 3 months
Change of dual task balance: sway area of Center of Pressure (CoP) displacements
Zeitfenster: baseline and 3 months
Sway area of CoP displacements will be assessed in mm^2 using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher sway area indicate worse balance.
baseline and 3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Limits of Stability (LOS): success rate
Zeitfenster: baseline and 3 months
Evaluations will be done by NedSVE/IBV balance platform. Indices: Max Excursions (%), Directional Control (%), Success (%), LOS rate (%) will be recorded during forward, backward, right and left side movements.
baseline and 3 months
Limits of Stability (LOS): time
Zeitfenster: baseline and 3 months
Evaluations will be done by NedSVE/IBV balance platform. Indices: Reaction Time (s), Confinement Time (s), will be recorded during forward, backward, right and left side movements.
baseline and 3 months
The Berg Balance Scale
Zeitfenster: baseline and 3 months
Balance will be assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable. Scoring ranges from 0-56, with higher scores indicating better balance. A score of <46 identifies an individual at risk for falls after stroke.
baseline and 3 months
Functional capacity: The Timed "Up & Go" test
Zeitfenster: baseline and 3 months
Timed "Up & Go" will be used to measure functional capacity. It is a simple test used to assess a person's mobility and requires both static and dynamic balance. Less time to complete the test in seconds implies better outcome.
baseline and 3 months
Functional capacity: Sit-to-stand test
Zeitfenster: baseline and 3 months
Sit-to-stand test (3 repetitions) will be used to measure functional capacity. Less time to complete the test in seconds implies better outcome.
baseline and 3 months
Functional capacity: 2-minutes walk test
Zeitfenster: baseline and 3 months
Evaluation of functional capacity during walking by using 2 minutes walk test. More distance covered in 2 minutes implies better outcome.
baseline and 3 months
Haemophilia Activities List (HAL)
Zeitfenster: baseline and 3 months

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. The score is obtained using a Likert scale with 5 options: always=2, mostly=3, sometimes=4, rarely=5 and never=6 (complemented by the option "impossible=1" for those people who can not perform such activity). Subscales are summed, with a total score from 0- 252 and higher values represent a worse outcome (greater self-perceived difficulty in carrying out the activities).
baseline and 3 months
Functional Independence Scale for Hemophilia (FISH)
Zeitfenster: baseline and 3 months

Observed activity limitations will be measured with the Functional Independence Scale for Hemophilia (FISH) as part of the Activity Domain.

The scale studies 8 activities (eating and grooming, bathing, dressing, chair, squatting, walking, stairs and running), which are classified into the three groups (Self care, Transfers and Locomotion) and their score ranges from 1 - 4 (1 being the highest dependency and 4 being the greatest independence to perform the exercises). Subscales are summed, with a total score from 8-32 and higher values represent a better outcome.

The FISH has been validated for use in developing countries. It consists of observed activities of daily living that are scored for quality.
baseline and 3 months
Quality of Life related with health: questionnaire
Zeitfenster: baseline and 3 months
Measured by a Specific questionnaire for Quality of Life related with health evaluation for adults with haemophilia (A36Haemophilia-QoL), which explores 9 areas. Subscales and score range: Physical health: 0-32; Daily activities: 0-16; Joints: 0-12; Pain: 0-8; Treatment satisfaction: 0-8; Difficulties treatment: 0-16; Emotional functioning: 0-20; Mental health: 0-12; Social activity: 0-20. Subscales are summed, with a total score from 0-144 and higher values represent a better outcome (more Quality of Life perceived).
baseline and 3 months
Kinesiophobia
Zeitfenster: baseline and 3 months
Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz P., 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
baseline and 3 months
Modified Falls Efficacy Scale (mFES)
Zeitfenster: baseline and 3 months
MFES is a 14-item questionnaire related to daily indoor and outdoor physical activities. It is a 10-point visual analog scale of confidence level in completing a particular activity (item) without falling, rated from 0 to 10, where 0 denotes not confident or sure at all, and 10 denotes completely confident or sure. The total score for the 14 items ranges from 0 to 140.
baseline and 3 months
Joint health status
Zeitfenster: baseline
Joint clinical evaluation of elbows, knees and ankles by using The Hemophilia Joint Health Score 2.1 (HJHS). The full score range goes from 0 to 124 points (0-20 points for each of the six joints evaluated, plus 4 points for the overall assessment of gait. 0 means no joint damage, whereas the higher the value, the higher the degree of arthropathy.
baseline

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Valencia

Ermittler

  • Hauptermittler: Felipe Querol-Fuentes, MD, PhD, University of Valencia

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. Januar 2020

Primärer Abschluss (Voraussichtlich)

1. Juni 2020

Studienabschluss (Voraussichtlich)

1. Oktober 2020

Studienanmeldedaten

Zuerst eingereicht

24. Juli 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Oktober 2019

Zuerst gepostet (Tatsächlich)

10. Oktober 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Januar 2020

Zuletzt verifiziert

1. Januar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • H20190326180948

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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