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

Primary Purpose

Quality of Life, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Progressive resistance training
Aerobic training
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Quality of Life focused on measuring Hemophilia, resistance training, aerobic exercise, Pakistan

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hemophilia welfare society karachi

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Aerobic training group

Resistance training group

Arm Description

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.

Outcomes

Primary Outcome Measures

Manual Muscle Testing - Daniel & Worthingham's
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
Hemophilia Joint Health Score (HJHS v2.1)
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.
Borg Rating of Perceived Exertion
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'.
HEP-Test-Q (Hemophilia and Exercise Project)
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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2021
Last Updated
March 22, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04892628
Brief Title
Effects of Progressive Resistance Training Compared With Aerobic Training in Patients With Hemophilia
Official Title
Measurement of Subjective and Objective Indices After Progressive Resistance Training Compared With Aerobic Training in Patients With Hemophilia: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 3, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Muscle Weakness
Keywords
Hemophilia, resistance training, aerobic exercise, Pakistan

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic training group
Arm Type
Other
Arm Description
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.
Arm Title
Resistance training group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Progressive resistance training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic training
Intervention Description
The control group will be administered a standard physical therapy intervention program which will consist of active muscle stretching and aerobic exercises.
Primary Outcome Measure Information:
Title
Manual Muscle Testing - Daniel & Worthingham's
Description
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
Time Frame
baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
Title
Hemophilia Joint Health Score (HJHS v2.1)
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. 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.
Time Frame
baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
Title
Borg Rating of Perceived Exertion
Description
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'.
Time Frame
baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
Title
HEP-Test-Q (Hemophilia and Exercise Project)
Description
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.
Time Frame
baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pereira
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hemophilia welfare society karachi
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31131517
Citation
Parhampour B, Dadgoo M, Vasaghi-Gharamaleki B, Torkaman G, Ravanbod R, Mirzaii-Dizgah I, Reza Baghaipour M, Saneii SH. The effects of six-week resistance, aerobic and combined exercises on the pro-inflammatory and anti-inflammatory markers in overweight patients with moderate haemophilia A: A randomized controlled trial. Haemophilia. 2019 Jul;25(4):e257-e266. doi: 10.1111/hae.13764. Epub 2019 May 26.
Results Reference
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Effects of Progressive Resistance Training Compared With Aerobic Training in Patients With Hemophilia

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