Effect of Combined Endurance Training on ADL and Walking in COPD Patients
ConditionCOPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). Pulmonary rehabilitation (PR), which has exercise as a major component, is considered a key treatment in the management of COPD since PR is effective in improving exercise tolerance, exercise-induced dyspnea and fatigue, and health-related quality of life. Rehabilitation is also effective in improving the time required to perform ADLs, reducing symptoms and disability. Studies show that rehabilitation protocols with upper limb exercises added to lower limb training are able to give additional benefits in terms of effort tolerance (endurance time at the arm ergometer and oxygen consumption) and reduction of dyspnea at iso-load.
The primary aim of this study is to evaluate whether the combined "arm and leg" training modality, compared to a gold standard protocol -involving only the lower limbs training- is more effective in improving ADL performance in terms of reduction of exercise time for a specific test (GLITTRE test).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
GOLD class 2-3 COPD
Forced Expiratory Volume in the first second (FEV1) between 30% and 70% of the predicted value
ability to walk and climb stairs without assistance
stable clinical condition (pH > 7.35)
Disqualifiers
chronic respiratory insufficiency on long-term oxygen therapy (LTOT)
severe orthopedic, neurological or cardiological comorbidities
cognitive impairment
recent exacerbation (within 15 days) requiring a change in therapy
Trial design
Design model
Parallel
Treatments tested in this trial
LL group
Other interventionThe program will include daily sessions of 90 minutes, for a total of 14 sessions, consisting of: 1. 60 minutes on a stationary bike for the lower limbs (2 sessions per day of 30 minutes) at moderate-high intensity; 2. 30 minutes of strengthening exercises for upper limbs (biceps, pectoral, latissimus dorsi) and lower limbs (quadriceps, gluteus and hamstrings) performed free body or with the aid of weights. All sessions will be supervised by a physiotherapist.
L+UL group
Other interventionThese patients will attend a rehabilitation program with daily sessions of 90 minutes, for a total of 14 sessions, consisting of: 1. 30 minutes on a stationary bike for the lower limbs (1 session of 30 minutes per day) at moderate-high intensity; 2. 30 minutes with arm-ergometer (1 daily session of 30 minutes) at moderate-high intensity; 3. 30 minutes of strengthening exercises for upper limbs (biceps, pectoral, latissimus dorsi) and lower limbs (quadriceps, gluteus and hamstrings) performed free body or with the aid of weights. All sessions will be supervised by a physiotherapist.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: lower limbs (LL) groupActive comparator 1 intervention
Group B: lower plus upper limbs (L+UL) groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in ADLs (GLITTRE test)
To evaluate the improvement in terms of change of exercise time for a specific test (GLITTRE test)
Time frame
Time Frame. From the date of randomization to the End of the program (up to 16 days)Secondary outcomes
1
Change in effort tolerance of the lower limbs
To evaluate the improvement in terms of change in the walked distance at 6 minutes walking test (6MWT)
Time frame
Time Frame. From the date of randomization to the End of the program (up to 16 days)2
Change in effort tolerance of the upper limbs
To evaluate the improvement in terms of change in Tlim (time to exhaustion) in the Unsupported Upper Limb Exercise Test (UULEX)
Time frame
Time Frame. From the date of randomization to the End of the program (up to 16 days)3
Change in the energy cost of walking (EC)
To evaluate the improvement in terms of change of the energy cost of walking with the EC test performed on a treadmill at a speed of 3.0 km/h for 6 minutes
Time frame
Time Frame. From the date of randomization to the End of the program (up to 16 days)Sponsors and contacts
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Source ClinicalTrials.gov