NCT02781233

Brief Summary

This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

May 18, 2016

Last Update Submit

October 15, 2018

Conditions

Haemophilia

Outcome Measures

Primary Outcomes (1)

  • Change in Muscle strength

    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

Secondary Outcomes (12)

  • Change in Timed Up and Go

    baseline and 8 weeks

  • Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )

    baseline and 8 weeks

  • Change in Bleedings

    daily (during the 8 weeks of intervention)

  • Change in viscoelastic properties (rectus femoris)

    baseline and 8 weeks

  • Change in sit-to-stand test

    baseline and 8 weeks

  • +7 more secondary outcomes

Study Arms (2)

Training group

EXPERIMENTAL

Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions.

Other: Progressive resistance training

Control group

PLACEBO COMPARATOR

Usual daily activities

Other: Normal daily activities

Interventions

Progressive resistance trainingOTHER

Progressive resistance training program

Training group
Normal daily activitiesOTHER

Usual daily activities

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

  • Calatayud J, Perez-Alenda S, Carrasco JJ, Cruz-Montecinos C, Andersen LL, Bonanad S, Querol F, Megias-Vericat JE, Casana J. Safety and Effectiveness of Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training on Physical Function and Pain in People With Hemophilia. Phys Ther. 2020 Aug 31;100(9):1632-1644. doi: 10.1093/ptj/pzaa106.

    PMID: 32525975DERIVED

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Felipe Querol-Fuentes, MD, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, PhD

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 24, 2016

Study Start

October 24, 2017

Primary Completion

June 25, 2018

Study Completion

June 25, 2018

Last Updated

October 18, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)