Effect of Home-base Exercise With Conical-PEP Device on Physical Performance and Quality of Life in COPD

NCT ID: NCT02790047

Last Updated: 2016-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-05-31

Brief Summary

The aim of this study to investigate the efficacy of a home-base exercise program with a new conical PEP device on physical performance and health related quality of life in COPD patients.

Detailed Description

The key pathophysiology of COPD is expiratory flow limit and hyperinflation that is a major factor related exertional dyspnea and exercise limitation. When expiratory minute volume( V ̇E) raise up while exercise, respiratory response by increase respiratory rate (RR) and tidal volume (VT), force exhalation occur lead to develop premature airway closer. These generate dynamic air tapping breath by breath and result in dynamic hyperinflation (DH). The DH limits VT expansion, increase respiratory muscle load, and it is a major cause related dyspnea and exercise termination. Furthermore, Pre-inflammatory products from the COPD lung contribute to another system, and provoke systemic inflammation lead to nutritional abnormalities, weight loss, skeletal muscle dysfunction, osteo-skeletal effect, cardiovascular effect and psychological effect. All of these affect the exercise tolerance and gradually affect physical activity and health-related quality of life (HRQL) as well.

COPD GOLD guideline states that goal for treatments of stable COPD comprise of relive symptoms, improve exercise tolerance, improve health status, prevent disease progression and reduce mortality. Several evidences have suggested an effect of pulmonary rehabilitation (PR) in patient with stable COPD and following acute exacerbation. Strong evidences reported that the PR program could improve exercise tolerance, reduce dyspnea, decrease fatigue and improve health-related quality of life.

The core stone of PR is an exercise program. Several types of exercise were published such as endurance exercise, interval exercise, strengthening exercise, respiratory muscle strengthening and breathing exercise. Most COPD patient stop exercise causes from dyspnea that related DH development during exercise. Previous studies reported various strategies to reduce DH development during exercise for extending exercise time or increase exercise capacity in immediate effect such as bronchodilators , hyperoxic breathing, heliox breathing, positive pressure therapy by non-invasive positive pressure ventilation (NIPPV), by pursed lip breathing (PLB) and by positive expiratory pressure (PEP) device.

The PEP therapy have been conventionally using for reduce premature airway closer by moving equal pressure point from distal to proximal, improve gas exchange and improve secretion clearance. In the past decade, the knowledge of dynamic hyperinflation in COPD patient has rapidly glowed up. The PEP device and PLB have used to reduce DH development during exercise that reported in only 5 studies. They expected that delay DH development, it may delay exertional dyspnea, and may result in improve exercise capacity.

Three studies reported DH parameter at pre and post exercise. Results indicated that using the PEP device can reduce DH when measuring immediate post exercise. However, effects of positive pressure therapy (PEP device and PLB) on exercise capacity were also inconclusive. But three studies showed positive effect of PEP therapy on exercise capacity.

Training effect of PEP therapy on physical performance and quality of life was present in two studies. The first study showed the benefit of breathing retraining (including PLB, and other breathing techniques) that were integrated to all daily activities and exercise program, superior than control group in peak oxygen consumption after 7th week of exercise program. The second study applied PLB to reduce DH during exercise program. They found that after ten sessions (within 3 to 4 weeks) of program, both PLB and control groups significantly improve 6 minute walk distance and quality of life, but non-significant effect between groups. To date there was only two studies of PEP therapy applying to exercise program, and results were not conclusive.

In spite of the PLB was wildly used, but positive pressure from this technique was reported about 5 cm H2O, it is lower boundary of therapeutic pressure range (5 to 20 cm H2O), this may result in a non-success of DH reduction. Consequently, The PEP device may be a convenient alternative way to generate positive pressure within therapeutic range for reduces DH during exercise or daily activities living. This may increase patient's physical performance and quality of life greater that exercise alone.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Exercise Therapy; Positive Expiratory Pressure; Physical Fitness; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Home-base exercise

Patients will receive intervention as following

1. A home-base exercise program

2. Health education

3. Breathing strategies for self secretion clearance

4. The medication following the COPD GOLD guidelines (2015)

Group Type: ACTIVE_COMPARATOR

A home-base exercise program

Intervention Type: OTHER

Duration of the program is 8 weeks A frequency of exercise session is 3 to 5 sessions per week A content of each exercise session includes

1. Stretching exercise (shoulder, trunk and leg muscles) to warm up for 5 to 10 minutes

2. Interval endurance exercise using a spot marching movement for 30 to 40 minutes. In each phase of spot marching exercise, patients will perform the exercise from 0 to 3 or 4 score of 10 score of a modified dyspnea Borg scale, they will record exercise the exercise duration time. Then, they will be required to rest until a modified dyspnea Borg scale < 1 score. Next, they will perform the next interval of spot marching exercise with the same protocol.

3. Stretching exercise (shoulder, trunk and leg muscles) to cool down for 5 to 10 minutes

Health education

Intervention Type: OTHER

Health education include

1. Knowledge of COPD disease

2. Smoking status and smoking cessation

3. Medication correctly

4. Self dyspnea management

5. Basic nutrition for COPD

ฺBreathing strategies for self secretion clearance

Intervention Type: OTHER

Using a modified active cycle breathing technique (mACBT) include

1. Control breathing

2. Pursed lip breathing (PLB)

3. Slow inhale with sustain thoracic expansion for 3 sec and exhale with PLB technique

4. Force expiratory technique (FET) with low to medium lung volume

5. Huffing or coughing

The medication following the COPD GOLD guidelines (2015)

Intervention Type: DRUG

Patients will receive medications following the COPD GOLD guidelines (2015). The medication names were listed below

1. Bata 2 agonist (short acting); Salbutamol (oral or inhaler), Terbutaline (oral)

2. Bata 2 agonist (long acting); Bambuterol (oral), Procaterol (oral), Salmeterol (inhaler), Formoterol (inhaler)

3. Xanthine derivative (sustained release theophylline)

4. Anticholinergic; Tiotropium(inhaler), Ipratropium bromide (inhaler)

5. Corticosteroids; Beclomethasone (inhaler), Budesonide(inhaler), Fluticasone(inhaler)

6. Combined anticholinergic+ Beta 2-agonist; Ipratropium+fenoterol (inhaler), Ipratropium+salbutamol (inhaler)

7. Combined Beta 2-agonist+ corticosteroids; Formoterol+ Budesonide(inhaler), Salmeterol+ Fluticasone(inhaler)

Home-base exercise with a PEP mask

Patients will receive intervention as following

1. A home-base exercise program with using a non-re-breathing face mask with conical-PEP device during an interval endurance spot marching exercise

2. Health education

3. Breathing strategies for self secretion clearance

4. The medication following the COPD GOLD guidelines (2015)

Group Type: EXPERIMENTAL

A non-re-breathing face mask with conical-PEP device

Intervention Type: DEVICE

Participant will use a non-re-breathing face mask with conical-PEP device during an interval endurance spot marching exercise.

A home-base exercise program

Intervention Type: OTHER

Duration of the program is 8 weeks A frequency of exercise session is 3 to 5 sessions per week A content of each exercise session includes

1. Stretching exercise (shoulder, trunk and leg muscles) to warm up for 5 to 10 minutes

2. Interval endurance exercise using a spot marching movement for 30 to 40 minutes. In each phase of spot marching exercise, patients will perform the exercise from 0 to 3 or 4 score of 10 score of a modified dyspnea Borg scale, they will record exercise the exercise duration time. Then, they will be required to rest until a modified dyspnea Borg scale < 1 score. Next, they will perform the next interval of spot marching exercise with the same protocol.

3. Stretching exercise (shoulder, trunk and leg muscles) to cool down for 5 to 10 minutes

Health education

Intervention Type: OTHER

Health education include

1. Knowledge of COPD disease

2. Smoking status and smoking cessation

3. Medication correctly

4. Self dyspnea management

5. Basic nutrition for COPD

ฺBreathing strategies for self secretion clearance

Intervention Type: OTHER

Using a modified active cycle breathing technique (mACBT) include

1. Control breathing

2. Pursed lip breathing (PLB)

3. Slow inhale with sustain thoracic expansion for 3 sec and exhale with PLB technique

4. Force expiratory technique (FET) with low to medium lung volume

5. Huffing or coughing

The medication following the COPD GOLD guidelines (2015)

Intervention Type: DRUG

Patients will receive medications following the COPD GOLD guidelines (2015). The medication names were listed below

1. Bata 2 agonist (short acting); Salbutamol (oral or inhaler), Terbutaline (oral)

2. Bata 2 agonist (long acting); Bambuterol (oral), Procaterol (oral), Salmeterol (inhaler), Formoterol (inhaler)

3. Xanthine derivative (sustained release theophylline)

4. Anticholinergic; Tiotropium(inhaler), Ipratropium bromide (inhaler)

5. Corticosteroids; Beclomethasone (inhaler), Budesonide(inhaler), Fluticasone(inhaler)

6. Combined anticholinergic+ Beta 2-agonist; Ipratropium+fenoterol (inhaler), Ipratropium+salbutamol (inhaler)

7. Combined Beta 2-agonist+ corticosteroids; Formoterol+ Budesonide(inhaler), Salmeterol+ Fluticasone(inhaler)

Interventions

A non-re-breathing face mask with conical-PEP device

Participant will use a non-re-breathing face mask with conical-PEP device during an interval endurance spot marching exercise.

Intervention Type: DEVICE

A home-base exercise program

Duration of the program is 8 weeks A frequency of exercise session is 3 to 5 sessions per week A content of each exercise session includes

1. Stretching exercise (shoulder, trunk and leg muscles) to warm up for 5 to 10 minutes

2. Interval endurance exercise using a spot marching movement for 30 to 40 minutes. In each phase of spot marching exercise, patients will perform the exercise from 0 to 3 or 4 score of 10 score of a modified dyspnea Borg scale, they will record exercise the exercise duration time. Then, they will be required to rest until a modified dyspnea Borg scale < 1 score. Next, they will perform the next interval of spot marching exercise with the same protocol.

3. Stretching exercise (shoulder, trunk and leg muscles) to cool down for 5 to 10 minutes

Intervention Type: OTHER

Health education

Health education include

1. Knowledge of COPD disease

2. Smoking status and smoking cessation

3. Medication correctly

4. Self dyspnea management

5. Basic nutrition for COPD

Intervention Type: OTHER

ฺBreathing strategies for self secretion clearance

Using a modified active cycle breathing technique (mACBT) include

1. Control breathing

2. Pursed lip breathing (PLB)

3. Slow inhale with sustain thoracic expansion for 3 sec and exhale with PLB technique

4. Force expiratory technique (FET) with low to medium lung volume

5. Huffing or coughing

Intervention Type: OTHER

The medication following the COPD GOLD guidelines (2015)

Patients will receive medications following the COPD GOLD guidelines (2015). The medication names were listed below

1. Bata 2 agonist (short acting); Salbutamol (oral or inhaler), Terbutaline (oral)

2. Bata 2 agonist (long acting); Bambuterol (oral), Procaterol (oral), Salmeterol (inhaler), Formoterol (inhaler)

3. Xanthine derivative (sustained release theophylline)

4. Anticholinergic; Tiotropium(inhaler), Ipratropium bromide (inhaler)

5. Corticosteroids; Beclomethasone (inhaler), Budesonide(inhaler), Fluticasone(inhaler)

6. Combined anticholinergic+ Beta 2-agonist; Ipratropium+fenoterol (inhaler), Ipratropium+salbutamol (inhaler)

7. Combined Beta 2-agonist+ corticosteroids; Formoterol+ Budesonide(inhaler), Salmeterol+ Fluticasone(inhaler)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• COPD patients (with FEV1 ≤70% predicted)

Exclusion Criteria

• Exacerbate within a month prior, which was a cause of admission to the hospital emergency room or been admitted to hospital.
• Are changed medicines within a month ago.
• Have been used home oxygen therapy.
• Have musculoskeletal or neuromuscular problem affecting balance and walking. and spot marching exercise.
• Using walking aid device.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thailand Research Fund

OTHER

Sponsor Role: collaborator

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Chatchai Phimphasak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chulee U Jones, Ph.D., PT

Role: STUDY_DIRECTOR

Khon Kaen University

Chatchai Phimphasak, M.Sc, PT

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

School of Physical Therapy, Faculty of Associated Medical Sciences

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status: NOT_YET_RECRUITING

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Chatchai Phimphasak, M.Sc., PT

Role: CONTACT

Phone: +66861779571

Email: chatmomo_chai@hotmail.com

Chulee U jones, Ph.D., PT

Role: CONTACT

Phone: +66845164169

Facility Contacts

Chatchai Phimphasak, M.Sc. (PT)

Role: primary

Other Identifiers

PHD/0082/2556

Identifier Type: -

Identifier Source: org_study_id