Clinical trial NCT04892628: 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
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Muscle Weakness
Keywords: Hemophilia
resistance training
aerobic exercise
Pakistan
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Manual Muscle Testing - Daniel & Worthingham's
timeFrame: baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
measure: Hemophilia Joint Health Score (HJHS v2.1)
timeFrame: baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
measure: Borg Rating of Perceived Exertion
timeFrame: baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
measure: HEP-Test-Q (Hemophilia and Exercise Project)
timeFrame: baseline and post intervention (week 8 - the analysis will be conducted on the first week immediately after the end of the training)
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Hemophilia welfare society karachi
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Pereira
role: PRINCIPAL_INVESTIGATOR
References:
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.