Isoinertial Training in Patients With COPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUniversidad Manuela Beltrán
About this trial
Isoinertial training is emerging as a potentially effective strategy to improve strength and functionality in older people diagnosed with chronic obstructive pulmonary disease (COPD), due to its influence on muscle mass and neuromuscular efficiency. COPD is characterized by systemic alterations, including peripheral muscle dysfunction; which contributes to patient functional limitation, and reduces patients' quality of life. Isoinertial training may improve the physiological response to effort, and also promote functional performance in this population. Hence, the aim of this study is to evaluate the effect of an isoinertial training program on muscle strength and functional capacity in patients with COPD during an 8-week intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
People between 50 - 80 years of age diagnosed with moderate or severe COPD
No acute exacerbations in the last 4 weeks
Sufficient functional capacity to exercise
Signed informed consent
Disqualifiers
Presence of neurological, musculoskeletal, or cardiovascular diseases that significantly limit exercise performance or compromise participant safety; including uncontrolled hypertension, recent myocardial infarction, unstable angina, severe osteoarthritis, stroke sequelae, or Parkinson's disease.
Contraindications to exercise participation according to medical evaluation.
Recent surgeries in the past 3 months
Simultaneous participation in other exercise programs
Trial design
Design model
Parallel
Treatments tested in this trial
Isoinertial training
DeviceSupervised isoinertial training: * Participants will perform a supervised isoinertial training program during 8 weeks of follow-up * The intervention will have a frequency of 2 to 3 weekly sessions * The program will include exercises aimed at strengthening the upper and lower limbs using a isoinertial device * The training load will be progressive to each participant and adjusted according to the individual response. * The program will be carried out in combination with usual pulmonary rehabilitation care.
Traditional rehabilitation (control group)
Other interventionTraditional treatment (control group) * Participants involved in the usual pulmonary rehabilitation program during 8 weeks with a frequency of 2-3 sessions per week. * This program includes low- to moderate-intensity aerobic exercise, joint mobility activities and general strengthening exercises using conventional resources according to the clinic's rehabilitation protocol. * No isoinertial training
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Supervised isoinertial trainingExperimental treatment 1 intervention
Group B: Traditional rehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in upper limb muscle strength using the Hand Grip Test (HGT)
Manual grip strength will be evaluated by dynamometry, as an indicator of peripheral muscle strength in patients with COPD.
Time frame
Baseline and 8-week follow-up2
Change in functional capacity by 6-minute walk test (6MWT)
The distance covered for 6 minutes will be evaluated as an indicator of exercise tolerance and functional capacity.
Time frame
Baseline and 8-week follow-up3
Lower limb functional performance
The number of repetitions performed in 30 seconds will be recorded as an indicator of functional strength-endurance in the lower limbs
Time frame
Baseline and 8-week follow-up4
Change in functional mobility using the Timed Up and Go Test (TUG)
The time needed to get up from a chair, walk, turn and sit down again will be measured, as an indicator of mobility and functional risk.
Time frame
Baseline and 8-week follow-upSecondary outcomes
1
Change in functional performance using 5 Times Sit-to-Stand Test (5STS)
Time required to perform 5 repetitions of standing and sitting will be measured, as a complementary indicator of lower limb function
Time frame
Baseline and 8-week follow-up2
Change in health-related quality of life through The Saint George's Respiratory Questionnaire (SGRQ)
The SGRQ will be applied to assess the symptoms, activity and impact of the respiratory disease. This score ranges from 0 to 100 points, a higher score indicates poor health.
Time frame
Baseline and 8-week follow-up3
Changes in Body Mass Index (BMI)
Body mass index (BMI) will be assessed to characterize participants' anthropometric status. BMI will be calculated as body weight divided by height squared and expressed in kilograms per square meter (kg/m\^2).
Time frame
Baseline and 8-week follow-up4
Changes in heart rate
Heart rate (bpm) will be measured using an automatic monitor
Time frame
Baseline and 8-week follow-upSponsors and contacts
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Source ClinicalTrials.gov