Clinical trial NCT04521959: The Effect Of Blood Flow Restrıcted Resistive And Aerobic Exercises in Chronic Obstructive Pulmonary Patients
Official title: The Effect Of Blood Flow Restrıcted Resistive And Aerobic Exercises in Chronic Obstructive Pulmonary Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Keywords: COPD, blood flow restriction, exercise
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomized controlled intervention groups will be formed.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: FEV1/FVC rate
timeFrame: eight weeks
measure: creatine kinase
timeFrame: eight weeks
measure: c reactive protein
timeFrame: eight weeks
measure: d-dimer
timeFrame: eight weeks
measure: total antioxidant status
timeFrame: eight weeks
measure: total oxidant status
timeFrame: eight weeks
measure: interleukin 6
timeFrame: eight weeks
measure: oxygen saturation
timeFrame: three times a week
measure: heart rate
timeFrame: three times a week
measure: six minute walk test
timeFrame: eight weeks
measure: ST george's respiratory questionnaire
timeFrame: eight weeks
measure: quadriceps muscle diameter
timeFrame: eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği
Study officials:
References:
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citation: Berzosa C, Cebrian I, Fuentes-Broto L, Gomez-Trullen E, Piedrafita E, Martinez-Ballarin E, Lopez-Pingarron L, Reiter RJ, Garcia JJ. Acute exercise increases plasma total antioxidant status and antioxidant enzyme activities in untrained men. J Biomed Biotechnol. 2011;2011:540458. doi: 10.1155/2011/540458. Epub 2011 Mar 9.
citation: Wilk M, Krzysztofik M, Gepfert M, Poprzecki S, Golas A, Maszczyk A. Technical and Training Related Aspects of Resistance Training Using Blood Flow Restriction in Competitive Sport - A Review. J Hum Kinet. 2018 Dec 31;65:249-260. doi: 10.2478/hukin-2018-0101. eCollection 2018 Dec.