Effects of Progressive Resistance Training Compared With Aerobic Training in Patients With Hemophilia

March 22, 2022 updated by: Felicianus Pereira, Dow University of Health Sciences

Measurement of Subjective and Objective Indices After Progressive Resistance Training Compared With Aerobic Training in Patients With Hemophilia: a Randomised Controlled Trial

This study aims to assess the effects of progressive resistance training compared with aerobic training, among those with hemophilia. Participants will be divided into two groups. The control group will receive an aerobic exercise protocol, and the resistance group will follow a resistance training program. Each group will receive a total of eight sessions. Target muscles are deltoids, biceps, triceps, quadriceps, hamstrings, and calves.

Subjective and objective assessment will be performed for each group, to determine the effectiveness of each intervention.

Study Overview

Detailed Description

Participant's height, weight and age will be recorded for pre-test anthropometric data. Height will be measured using a stadiometer, and weight will be measured with an electronic scale.

Treatment sessions will be conducted twice a week, for 8 weeks. The control group will be administered a standard physical therapy intervention program which will consist of active muscle stretching and aerobic exercises.

Exercises will include:

  • Flexion, extension and abduction at the shoulder joint for anterior, middle and posterior fibers of deltoid
  • Flexion and extension at the elbow for biceps and triceps trachii
  • Flexion and extension at the knee joint for quadriceps and hamstring muscles
  • Plantar flexion at the ankle joint for gastrocnemius and soleus Three sets of ten repetitions of each exercise will be done.

The intervention group will undergo a progressive resistance training program consisting of active muscle stretching and resistance training. Exercise for intervention group will consist of:

  • Resisted flexion, extension and abduction at the shoulder joint for anterior, middle and posterior deltoid, using dumbbells
  • Resisted flexion and extension at the elbow for biceps and triceps trachii, using dumbbells
  • Resisted flexion and extension of knee joint for quadriceps and hamstring muscles, using therabands
  • Resisted dorsiflexion and plantar flexion of gastrocnemius and soleus, using therabands

Resistance will be increased on basis of progressive overload principle. Three sets of ten repetitions will be performed per muscle group. Initial weight of the dumbbells will be 1kg and will be increased by 0.5kg per week. Therabands used will be Yellow, Red, Green and Blue. Resistance for therabands will be upgraded every two weeks. Treatment time per group will be approximately 40 minutes. Exercises will be progressed in a gradual manner to give participants time to build muscle strength.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sindh
      • Karachi, Sindh, Pakistan
        • Hemophilia welfare society karachi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinically diagnosed with hemophilia A or B (mild to moderate hemophilia (mild hemophilia - 0.05-0.4 IU, moderate hemophilia - 0.01-0.05 IU)
  • undergo pre- and post-program objective assessment of manual muscle testing and Hemophilia Joint Health Score, as well as subjective assessment of and Rating of Perceived Exertion.
  • willing to train two times a week
  • males and females between 18 to 45 years of age.
  • those who can ambulate without assistance

Exclusion Criteria:

  • unable to attend exercise sessions for the complete duration of the study
  • those who have had surgery performed 6 weeks before, or in duration of training (due to any disability)
  • involvement in any other training, or rehabilitation, during study
  • change in medicine within the study
  • history of major bleeding episodes that could pose a risk
  • history of factor 8 or factor 9 inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Aerobic training group

The control group will be administered a standard physical therapy intervention program which will consist of active muscle stretching and aerobic exercises.

Exercises will include:

  • Flexion, extension and abduction at the shoulder joint for anterior, middle and posterior fibers of deltoid
  • Flexion and extension at the elbow for biceps and triceps trachii
  • Flexion and extension at the knee joint for quadriceps and hamstring muscles
  • Plantar flexion at the ankle joint for gastrocnemius and soleus

Three sets of ten repetitions of each exercise will be done.

The control group will be administered a standard physical therapy intervention program which will consist of active muscle stretching and aerobic exercises.
Experimental: Resistance training group

The intervention group will undergo a progressive resistance training program consisting of active muscle stretching and resistance training. Exercise for intervention group will consist of:

  • Resisted flexion, extension and abduction at the shoulder joint for anterior, middle and posterior deltoid, using dumbbells
  • Resisted flexion and extension at the elbow for biceps and triceps trachii, using dumbbells
  • Resisted flexion and extension of knee joint for quadriceps and hamstring muscles, using therabands
  • Resisted dorsiflexion and plantar flexion of gastrocnemius and soleus, using therabands

Resistance will be increased on basis of progressive overload principle. Three sets of ten repetitions will be performed per muscle group. Initial weight of the dumbbells will be 1kg and will be increased by 0.5kg per week.

Resistance training of upper limb and lower limb muscles. Resistance will be increased on a weekly basis. Dumbbells and therabands will be used to provide resistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manual Muscle Testing - Daniel & Worthingham's
Time Frame: baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)

An objective marker to determine muscle strength. It ranges from 0-5

0 no movement of muscle

  1. flickering movement of muscle
  2. full range of motion in a gravity minimized position
  3. full range of motion against gravity, without resistance
  4. muscle can hold against moderate resistance
  5. muscle can hold against maximal resistance
baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
Hemophilia Joint Health Score (HJHS v2.1)
Time Frame: baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)

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. It can be used when there is a need for orthopedic intervention, or as an outcome measure of physiotherapy interventions.

A scoring system is present, which combines the score of these questions, with a global gait score, to give an overall score. The greater the score, the poorer the outcome.

The HJHS 2.1 provides a total score (higher score is worse; max=124), joint specific scores, and a global gait score.

baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
Borg Rating of Perceived Exertion
Time Frame: baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)

The second subjective marker. This will be used to assess the subjective workload of exercises, and to note if exercise intensity decreases over time.

The values range from 6-20, with 6 rated as 'no exertion', and 20 rated as 'maximal exertion'.

baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
HEP-Test-Q (Hemophilia and Exercise Project)
Time Frame: baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)

The subjective marker of this study. This measure will assess the quality of life. It is a scale specifically designed for people with hemophilia.

The HEP-Test-Q consists of 25 items pertaining to 4 domains 'mobility', 'strength & coordination', 'endurance' and 'body perception' and one single item, which assesses changes in physical functioning in comparison to the previous year.

The recall period for the assessment of physical functioning is over "the past four weeks".

The response options range on a 5-point Likert scale from "never" to "always".

Some of the items have to be re-coded. Subscales and the total score are transformed to a scale of 0-100 with high scores indicating better physical functioning.

baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pereira, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 14, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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