COPD: Blood Flow Restricted Exercise in Chronic Obstructive Pulmonary Disease

Sponsor
Medipol University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04521959
Collaborator
(none)
50
1
2
8.3
6

Study Details

Study Description

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 = 25) 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 40-80% intensity will be applied to the second group (n = 25), PRE and AE (PRE + AE group) performed at the same intensity and duration without BFR.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood flow restricted and normal aerobic exercise and resistance exercise
N/A

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 = 25) accompanied by CAC; Progressive resistance exercise (DE) 3 times a week, 1RMx 30% intensity, 10 repetitions, 3 sets, 30 seconds rest interval, and cycling after 5 minutes rest, progressive aerobic exercise in the target heart rate range of 40-80% intensity (AE ) (KAK DE + AE group) will be applied.

To the second group (n = 25) without CAC; 3 times a week, 8 weeks, 1RMx 30% intensity, 10 repetitions, 3 sets, 30 seconds of rest interval, and after 5 minutes of rest, AE (DE + AE group) 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 CAC 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two randomized controlled intervention groups will be formed.Two randomized controlled intervention groups will be formed.
Masking:
Single (Investigator)
Masking Description:
50 COPD patients will be divided into two equal groups according to age, gender and disease severity.
Primary Purpose:
Treatment
Official Title:
The Effect of Resistance and Aerobic Exercises With Blood Flow Restricted in COPD
Actual Study Start Date :
Aug 19, 2020
Anticipated Primary Completion Date :
Apr 27, 2021
Anticipated Study Completion Date :
Apr 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Blood Flow Restricted Aerobic and Resistance Exercise Group

kan akımı kısıtlanarak.direnç ve bisikletle aerobik egzersiz uygulanacak

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

Active Comparator: Normal aerobik ve direnç egzersiz grubu

Normal şartlarda aerobik ve direnç egzersizi uygulanacak

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

Outcome Measures

Primary Outcome Measures

  1. FEV1/FVC rate [eight weeks]

    respiratory function test

  2. creatine kinase [eight weeks]

    muscle breakdown marker

  3. c reactive protein [eight weeks]

    thrombus formation risk marker

  4. d-dimer [eight weeks]

    venous thromboembolism marker

  5. total antioxidant status [eight weeks]

    oxidative stress marker

  6. total oxidant status [eight weeks]

    oxidative stress marker

  7. interleukin 6 [eight weeks]

    inflammation marker

  8. oxygen saturation [three times a week]

    blood gas test

  9. heart rate [three times a week]

    for exercise dose determination

  10. six minute walk test [eight weeks]

    strength evaluation

  11. ST george's respiratory questionnaire [eight weeks]

    used to evaluate the effects of respiratory disease's symptoms and illness

  12. quadriceps muscle diameter [eight weeks]

    Measurement of change in muscle volume

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 78 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği Karabük Turkey 78600

Sponsors and Collaborators

  • Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmet Gunes, PhD Student, Medipol University
ClinicalTrials.gov Identifier:
NCT04521959
Other Study ID Numbers:
  • istanbul medipol university
First Posted:
Aug 21, 2020
Last Update Posted:
Dec 29, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmet Gunes, PhD Student, Medipol University

Study Results

No Results Posted as of Dec 29, 2020