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The Effect Of Blood Flow Restrıcted Resistive And Aerobic Exercises in Chronic Obstructive Pulmonary Patients

The Effect Of Blood Flow Restrıcted Resistive And Aerobic Exercises in Chronic Obstructive Pulmonary Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04521959
Acronym
COPD
Enrollment
40
Registered
2020-08-21
Start date
2020-08-19
Completion date
2021-05-25
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd

Keywords

COPD, blood flow restriction, exercise

Brief summary

Patients with chronic obstructive pulmonary disease (COPD) classified by a pulmonologist in accordance with the GOLD criteria will be randomly divided into 2 groups. The first group (n = 20) was accompanied by blood flow restriction (CAC), 3 times a week, 8 weeks, 1RMx 30% intensity, 10 repetitions, 3 sets, 30 seconds rest interval, progressive resistance exercise (PRE) and after 5 minutes of rest by cycling. Progressive aerobic exercise (AE) (BFR PRE + AE group) in the target heart rate range of 50-80% intensity will be applied to the second group (n = 20), PRE and AE (PRE + AE group) performed at the same intensity and duration without BFR.

Detailed description

Determination of application groups: Patients with chronic obstructive pulmonary disease (COPD) classified by a pulmonologist in accordance with the GOLD criteria will be randomly divided into 2 groups and application groups will be determined. Applications to be made: The first group (n = 20) accompanied by BFR; Progressive resistance training (RT) 3 times a week, 1RMx 30% intensity, 10 repetitions, 3 sets, 30 seconds rest interval, and cycling after 5 minutes rest, progressive aerobic training (AT)in the target heart rate range of 40-80% intensity will be applied. To the second group (n = 20) without BFR; 3 times a week, 8 weeks, 1RMx 30% intensity, 10 repetitions, 3 sets, 30 seconds of rest interval, and after 5 minutes of rest will be applied in the target heart rate range of 40-80%, which is done by cycling. Calculation of 1RM: Epley formula will be used in the calculation. According to this; 1 RM = (1 + .0333 x number of repetitions) x weight removed. Progress in resistance exercise; According to the modified borg scale (MBS), the amount of the lifted weight calculated on the basis of the increase in the 1RM value measured in every three consecutive sessions will be provided by increasing the amount of weight, on the condition that it remains between 4-6 intensity. This too; It will be calculated from the formula Target heart rate = (Maximal heart rate-resting heart rate) x% desired intensity ratio + resting heart rate. The target occlusion amount in the lower extremity will be calculated by calculating 45% of the complete occlusion rates reported by Michael et al. The proximal border of the thigh cuffs in the BFR group will be tied at the level of the gluteal lines on both sides. Exercise tolerance and dyspnea condition; Measurement properties in COPD will be evaluated using a modified Borg scale (MBS), which has well-defined characteristics. Individuals will use bronchodilators approved by their physician before each trial and continue drug therapy throughout the study. The target aerobic exercise intensity will be reached in the last minute of the first five-minute warm-up period by maintaining a 4-6 feeling of dyspnea in the MBS, by increasing pedal resistance and speed. The intensity increase will be increased by 5% for each subsequent session and the target heart rate will be limited to 80%. In case of extreme shortness of breath, the intensity of exercise will be reduced down to the resting heart rate. In case of oxygen desaturation (85%) during interventions, the intervention will be suspended until the next session. Aerobic exercise study protocol: warm-up at 50 RPM speed and lowest pedal resistance for the first 4 minutes, reaching the target exercise intensity range in the next 1 min, aerobic training at the target heart rate range and appropriate MBS for the next 20 minutes, the last 5 minutes It will be applied in the form of cooling. The duration will be reduced in case of extreme shortness of breath, fatigue and muscle pain due to increased exercise volume. The distance, calories, and maximum speed values measured during the first, 9 and 24 sessions will be recorded. Before the study and at the end of the 8th week, oxidative stress markers (plasma protein carbonyl concentration, lipid hydroperoxides, total antioxidant capacity (TAK)), muscle damage status (creatine phosphokinase, myoglobin), anti-inflammatory response (interleukin 6 (IL-6), risk of venous thromboembolism and thrombus formation (D-dimer, thrombin-antithrombin 3 component (TAT), c-reactive protein (CRP), fibrinogen), body mass index, respiratory function tests (FEV1, FVC), oxygen saturation and heart rate ( pulse oximetry), six-minute walking test, and quality of life (SF-36) will be evaluated at least 6 hours prior to taking medication. The change in the quadriceps muscle mass will be examined by a radiologist who is not involved in the study, by measuring the transverse and anteroposterior lengths of the relevant muscle using Toshiba aplio 300 brand ultrasound device. Statistical evaluation of results: Paired t-test, repeated measurement analysis of variables (RMANOVA), Kolmogorov-Smirnov test, post hoc contrast analysis, bonferroni correction will be used in the statistical analysis of intervention results.

Interventions

PROCEDUREBlood flow restricted and normal aerobic exercise and resistance exercise

Interventions of the same duration and intensity will be applied to two groups.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

40 COPD patients will be randomised divided into two equal groups according to age, gender and disease severity.

Intervention model description

Two randomized controlled intervention groups will be formed.

Eligibility

Sex/Gender
ALL
Age
40 Years to 78 Years
Healthy volunteers
Yes

Inclusion criteria

* Being diagnosed with mild to severe COPD according to GOLD criteria in the age range of 40-78 * No drug change for at least 30 days * Not participating in a structured activity program for at least six months * Have the ability to cooperate.

Exclusion criteria

* Presence of any pathology that limits physical activity performance * Presence of severe or unstable heart disease * Presence of peripheral artery disease * Being in an exacerbation period of the disease * Presence of another active disease (rheumatic, oncological, traumatic etc.) * Any neurological or orthopedic disease that prevents exercise

Design outcomes

Primary

MeasureTime frameDescription
FEV1/FVC rateeight weeksrespiratory function test
creatine kinaseeight weeksmuscle breakdown marker
c reactive proteineight weeksthrombus formation risk marker
d-dimereight weeksvenous thromboembolism marker
total antioxidant statuseight weeksoxidative stress marker
total oxidant statuseight weeksoxidative stress marker
interleukin 6eight weeksinflammation marker
oxygen saturationthree times a weekblood gas test
heart ratethree times a weekfor exercise dose determination
six minute walk testeight weeksstrength evaluation
ST george's respiratory questionnaireeight weeksused to evaluate the effects of respiratory disease's symptoms and illness
quadriceps muscle diametereight weeksMeasurement of change in muscle volume

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026