Quality of LifeNCT04892628
Effects of Progressive Resistance Training Compared With Aerobic Training in Patients With Hemophilia
A study testing Progressive resistance training and Aerobic training in people with Quality of Life and Muscle Weakness, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Quality of Life, Muscle Weakness
- What is being tested?
- Progressive resistance training and Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Apr 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality of Life, Muscle Weakness
- Being tested
- Progressive resistance training, Aerobic training
- Keywords
- Hemophilia, resistance training, aerobic exercise, Pakistan
- Medical subject headings
- Muscle Weakness, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance trainingOther
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 trainingOther
The control group will be administered a standard physical therapy intervention program which will consist of active muscle stretching and aerobic exercises.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training group | Other | 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. Receives: Other: Aerobic training |
| Resistance training group | Experimental | 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. Receives: Other: Progressive resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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.
Measured: 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
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'.
Measured: 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)
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.
Measured: baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start3 Apr 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felicianus Pereira, Dow University of Health Sciences
- Investigators
- Pereira, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892628
- Sponsor's protocol ID
- Hem_resistance_aerobic_pk
- Status last verified
- Mar 2022
- First submitted
- 4 May 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31131517
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Subjective and Objective Indices After Progressive Resistance Training Compared With Aerobic Training in Patients With Hemophilia: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04892628
- Acronym / sponsor ID
- Hem_resistance_aerobic_pk
- Conditions
- Quality of Life, Muscle Weakness
- Keywords
- Hemophilia, resistance training, aerobic exercise, Pakistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic training group | Other | Other: Aerobic trainingThe 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. |
| Resistance training group | Experimental | Other: Progressive resistance trainingThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive resistance trainingResistance 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. | Other | Resistance training group |
| Aerobic trainingThe control group will be administered a standard physical therapy intervention program which will consist of active muscle stretching and aerobic exercises. | Other | Aerobic training group |
Primary outcome
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
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.
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'.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 31131517Parhampour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pereira principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance training and Aerobic training in people with Quality of Life and Muscle Weakness, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04892628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.