Health TrialsbyHealthPanel

Impact of Inspiratory Muscle Training Post-Burn

ConditionBurn
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorCairo University

About this trial

Pulmonary dysfunction can be developed as a result of complications caused by direct thermal injury to the respiratory tract, smoke irritations, and respiratory tract infection. Although the survival rates of patients with burn injury have increased because of improved acute management, pulmonary complications have continued to be the main cause of mortality in patients with burns. The patients who survive suffer from persistent physiological impairments, limited aerobic capacity, increased skeletal muscle catabolism, and decreased muscle strength/endurance. Rehabilitation strategies for the long-term recovery in patients with burns aim to improve the physical function and independence in daily activities.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with inhalation injury after thermal burn injury including face and chest

with 40-60 % of total body surface area (%TBSA)

Partial or full thickness burns that either recovered spontaneously or healed by skin grafting

Age (20-50) years.

Disqualifiers

Cerebrovascular disease

Heavy smokers

Open or unhealed wounds

Chest physical therapy before enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inspiratory muscle training

    Device

    Participants in the experimental group will receive Inspiratory muscle training device, in addition to conventional physical therapy program. Initially, participants will be asked to perform three sets of 30 breaths on the POWER breathe to adjust the load and become familiar with the device. The training will include six 30-breath sets each day, divided into two sessions each. There is a one-minute rest time between each set. The inspiratory muscle load for training will be 50% of maximum inspiratory pressure (MIP), and it will be reviewed and changed weekly.

  • Conventional physical therapy

    Other intervention

    Conventional physical therapy exercise program in the form of respiratory physical therapy, balance and aerobic exercises.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Study group (Inspiratory muscle training)Experimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Respiratory muscle strength (Maximum Inspiratory Pressure)

Maximum Inspiratory Pressure (MIP): Inspiratory muscle strength will be assessed by measuring the maximum inspiratory pressure (MIP) using a respiratory pressure meter. MIP will be recorded in cmH₂O, with higher values indicating greater inspiratory muscle strength.

Time frame
8 weeks

Secondary outcomes

1

Respiratory muscle strength (Maximum expiratory Pressure)

Maximum Expiratory Pressure (MEP): Expiratory muscle strength will be assessed by measuring the maximum expiratory pressure (MEP) using a respiratory pressure meter. MEP will be recorded in cmH₂O, with higher values indicating greater expiratory muscle strength.

Time frame
8 weeks
2

Balance

Static and dynamic balance of the participants will be assessed through the Berg Balance Scale (BBS) where the patient has to perform 14 predetermined physical tasks assessing different aspects of balance. These include static, anticipatory, dynamic and sensory balance. Each task will be scored from 0 to 4 where 4 indicates the person can complete the task independently with a final maximal score of 56. Higher scores indicate better balance performance.

Time frame
8 weeks
3

Postural stability (Overall Stability Index)

Overall Stability Index (OSI): Postural stability will be assessed using the Biodex Postural Stability System (Biodex Medical Systems, Shirley, NY, USA). The Overall Stability Index (OSI) will be recorded as an indicator of overall postural stability, with lower values indicating better stability.

Time frame
8 weeks
4

Postural stability (Anterior-Posterior Index)

Anterior-Posterior Index (API): The Anterior-Posterior Stability Index (API) will be measured using the Biodex Postural Stability System (Biodex Medical Systems, Shirley, NY, USA) to assess postural stability in the anterior-posterior direction. Lower values indicate better stability.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: