search
Back to results

A Progressive Resistance Training Program in Patients With Haemophilia

Primary Purpose

Haemophilia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Progressive resistance training
Normal daily activities
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Haemophilia

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Training group

Control group

Arm Description

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

Usual daily activities

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in Timed Up and Go
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.
Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )
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).
Change in Bleedings
Number of Bleedings During the study
Change in viscoelastic properties (rectus femoris)
Myoton Pro
Change in sit-to-stand test
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.
Change in Haemophilia Activities List questionnaire
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.
Change in The Haemophilia Joint Health Score (HJHS)
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.
Change in Pain
11-point numerical pain rating scale with higher score meaning higher pain
Change in workability index
workability index with single question
Change in analgesics use (days/week)
The number of days the participants used analgesics during the last week
Change in Range Of Motion (ROM)
elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer
Change in Kinesiophobia
Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement

Full Information

First Posted
May 18, 2016
Last Updated
October 15, 2018
Sponsor
University of Valencia
Collaborators
Shire
search

1. Study Identification

Unique Protocol Identification Number
NCT02781233
Brief Title
A Progressive Resistance Training Program in Patients With Haemophilia
Official Title
The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
June 25, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Shire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training group
Arm Type
Experimental
Arm Description
Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Usual daily activities
Intervention Type
Other
Intervention Name(s)
Progressive resistance training
Intervention Description
Progressive resistance training program
Intervention Type
Other
Intervention Name(s)
Normal daily activities
Intervention Description
Usual daily activities
Primary Outcome Measure Information:
Title
Change in Muscle strength
Description
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).
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Timed Up and Go
Description
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.
Time Frame
baseline and 8 weeks
Title
Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )
Description
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).
Time Frame
baseline and 8 weeks
Title
Change in Bleedings
Description
Number of Bleedings During the study
Time Frame
daily (during the 8 weeks of intervention)
Title
Change in viscoelastic properties (rectus femoris)
Description
Myoton Pro
Time Frame
baseline and 8 weeks
Title
Change in sit-to-stand test
Description
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.
Time Frame
baseline and 8 weeks
Title
Change in Haemophilia Activities List questionnaire
Description
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.
Time Frame
baseline and 8 weeks
Title
Change in The Haemophilia Joint Health Score (HJHS)
Description
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.
Time Frame
baseline and 8 weeks
Title
Change in Pain
Description
11-point numerical pain rating scale with higher score meaning higher pain
Time Frame
baseline and 8 weeks
Title
Change in workability index
Description
workability index with single question
Time Frame
baseline and 8 weeks
Title
Change in analgesics use (days/week)
Description
The number of days the participants used analgesics during the last week
Time Frame
baseline and 8 weeks
Title
Change in Range Of Motion (ROM)
Description
elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer
Time Frame
baseline and 8 weeks
Title
Change in Kinesiophobia
Description
Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Querol-Fuentes, MD, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32525975
Citation
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.
Results Reference
derived

Learn more about this trial

A Progressive Resistance Training Program in Patients With Haemophilia

We'll reach out to this number within 24 hrs