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

NCT ID: NCT04892628

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-03
• Study Completion Date: 2021-09-30

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.

Conditions

Quality of Life; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Aerobic training

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Progressive resistance training

Intervention Type: 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.

Interventions

Progressive resistance training

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

Aerobic training

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Felicianus Pereira

Principal Investigator - Postgraduate Trainee

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pereira

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

Hemophilia welfare society karachi

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 31131517 (View on PubMed)

Other Identifiers

Hem_resistance_aerobic_pk

Identifier Type: -

Identifier Source: org_study_id