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

Copd Clinical Trial

— COPD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04521959
• Other study ID #: istanbul medipol university
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: April 15, 2024

Study information

• Verified date: March 2024
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: April 15, 2024
• Est. primary completion date: March 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Copd

Intervention

Procedure:
• Blood flow restricted and normal aerobic exercise and resistance exercise
Interventions of the same duration and intensity will be applied to two groups.

Locations

Country	Name	City	State
Turkey	Karabük Üniversitesi Arastirma Hastanesi Gögüs Hastaliklari Klinigi	Karabük

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

Kacin A, Strazar K. Frequent low-load ischemic resistance exercise to failure enhances muscle oxygen delivery and endurance capacity. Scand J Med Sci Sports. 2011 Dec;21(6):e231-41. doi: 10.1111/j.1600-0838.2010.01260.x. Epub 2011 Mar 8. — View Citation

Loenneke JP, Allen KM, Mouser JG, Thiebaud RS, Kim D, Abe T, Bemben MG. Blood flow restriction in the upper and lower limbs is predicted by limb circumference and systolic blood pressure. Eur J Appl Physiol. 2015 Feb;115(2):397-405. doi: 10.1007/s00421-01 — View Citation

Nolan CM, Rochester CL. Exercise Training Modalities for People with Chronic Obstructive Pulmonary Disease. COPD. 2019 Dec;16(5-6):378-389. doi: 10.1080/15412555.2019.1637834. Epub 2019 Nov 4. — View Citation

Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Fro — View Citation

Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1. — View 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-2018-01 — View Citation

Wilson JM, Lowery RP, Joy JM, Loenneke JP, Naimo MA. Practical blood flow restriction training increases acute determinants of hypertrophy without increasing indices of muscle damage. J Strength Cond Res. 2013 Nov;27(11):3068-75. doi: 10.1519/JSC.0b013e31 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1/FVC rate	respiratory function test	eight weeks
Primary	creatine kinase	muscle breakdown marker	eight weeks
Primary	c reactive protein	thrombus formation risk marker	eight weeks
Primary	d-dimer	venous thromboembolism marker	eight weeks
Primary	total antioxidant status	oxidative stress marker	eight weeks
Primary	total oxidant status	oxidative stress marker	eight weeks
Primary	interleukin 6	inflammation marker	eight weeks
Primary	oxygen saturation	blood gas test	three times a week
Primary	heart rate	for exercise dose determination	three times a week
Primary	six minute walk test	strength evaluation	eight weeks
Primary	ST george's respiratory questionnaire	used to evaluate the effects of respiratory disease's symptoms and illness	eight weeks
Primary	quadriceps muscle diameter	Measurement of change in muscle volume	eight weeks