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NCT Number: NCT04892628

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

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.

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Key information

Conditions

Quality of Life Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hemophilia welfare society karachi

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive resistance training

Other

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.

Aerobic training

Other

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

Primary outcomes

  1. 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

    • flickering movement of muscle
    • full range of motion in a gravity minimized position
    • full range of motion against gravity, without resistance
    • muscle can hold against moderate resistance
    • muscle can hold against maximal resistance

  2. 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.

  3. 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'.

  4. 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 19, 2021
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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