A Progressive Resistance Training Program in Patients With Haemophilia

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

Study Overview

• Status: Completed
• Conditions: Haemophilia
• Intervention / Treatment: Other: Normal daily activities; Other: Progressive resistance training

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training group; 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; Progressive resistance training program
Placebo Comparator: Control group; Usual daily activities	Other: Normal daily activities; Usual daily activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and 8 weeks
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).	baseline and 8 weeks
Change in Bleedings	Number of Bleedings During the study	daily (during the 8 weeks of intervention)
Change in viscoelastic properties (rectus femoris)	Myoton Pro	baseline and 8 weeks
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.	baseline and 8 weeks
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.	baseline and 8 weeks
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.	baseline and 8 weeks
Change in Pain	11-point numerical pain rating scale with higher score meaning higher pain	baseline and 8 weeks
Change in workability index	workability index with single question	baseline and 8 weeks
Change in analgesics use (days/week)	The number of days the participants used analgesics during the last week	baseline and 8 weeks
Change in Range Of Motion (ROM)	elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer	baseline and 8 weeks
Change in Kinesiophobia	Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement	baseline and 8 weeks

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Shire
• Investigators: Principal Investigator: Felipe Querol-Fuentes, MD, PhD, University of Valencia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimate): May 24, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: H15-29504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No