Effects Of Low-Load Blood Flow Restriction Training Of The Upper Extremity In Patients With Chronic Obstructive Pulmonary Disease

NCT07469111 | Recruiting

• 1 other identifier: 4006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airflow limitation, progressive dyspnea, and peripheral muscle dysfunction, significantly impairing functional capacity and quality of life. Although the combined implementation of aerobic and resistance exercises is recommended in pulmonary rehabilitation programs, early-onset ventilatory limitation in individuals with COPD often hinders tolerance to high exercise intensities. This limitation increases the need for alternative exercise approaches targeting peripheral muscle adaptations. Low-load blood flow restriction training (LL-BFRT), which enables improvements in muscle strength with low mechanical loads, has emerged as a potential option for this patient population. However, evidence regarding the effects of LL-BFRT in individuals with COPD-particularly on upper extremity muscles-remains limited. The aim of this study is to comparatively investigate the effects of LL-BFRT and sham-BFRT, both administered in addition to an aerobic exercise program in individuals diagnosed with stage II and III COPD, on upper extremity muscle strength, upper extremity functional capacity, activities of daily living performance, quality of life, functional exercise capacity, muscle oxygenation, and respiratory parameters. The study is designed as a randomized controlled, single-blind, quasi-experimental interventional trial. The expected outcomes are that LL-BFRT may enhance upper extremity muscle strength and functional capacity, improve activities of daily living and quality of life, and increase exercise tolerance due to its applicability at low mechanical loads. Furthermore, findings related to muscle oxygenation and respiratory parameters are anticipated to provide clinical evidence regarding the physiological effects of LL-BFRT on peripheral muscle adaptations. These results are expected to guide the integration of LL-BFRT as an alternative and safe approach in upper extremity exercise prescription within pulmonary rehabilitation programs, support clinical decision-making processes, and establish a scientific foundation for future research.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Blood Flow Restriction Training (BFRT)

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Los Load Resistance Exercise; Upper Extremity Function; Muscle Strength; Blood Flow Restriction Training (BFRT)

Outcome Measures

Primary Outcomes (1)

• Upper Extremity Functional Capacity

  Upper extremity functional capacity and endurance will be assessed using the 6-Minute Pegboard \& Ring Test (6-PBRT). During the test, participants will be seated in front of a pegboard and instructed to use both hands simultaneously to transfer as many rings as possible from two lower pegboards positioned at shoulder level to two upper pegboards located 20 cm above, and then back to the lower boards. The test duration is 6 minutes. Prior to the actual test, participants will be allowed to practice by transferring a few rings to familiarize themselves with the procedure. During the test, the physiotherapist will provide standardized verbal encouragement every minute to motivate the participant. At the end of the 6 minutes, the total number of rings transferred throughout the test will be recorded as the final score (16).

  Pre- and post-intervention (week 8).

Secondary Outcomes (6)

• Pulmonary Function Assessment

  Pre- and post-intervention (week 8).

• Muscle Strength Assestment

  Pre-post ıntervention (week 8)

• Activity Of Daily Living Assestment

  Pre-post ıntervention (week 8)

• Quality Of Life Assestment

  Pre-post ıntervention (week 8)

• Functional Capacity

  Pre-post ıntervention (week 8)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive an 8-week upper extremity aerobic exercise program combined with low-load blood flow restriction training targeting upper extremity muscles.

Other: Low-Load Blood Flow Restriction Training (LL-BFRT) + Aerobic Exercise

Control Group

SHAM COMPARATOR

Participants will receive the same 8-week upper extremity aerobic exercise program combined with sham blood flow restriction training with non-therapeutic cuff pressure.

Other: Sham Low-Load Blood Flow Restriction Training (LL-BFRT) + Aerobic Exercise

Interventions

Low-Load Blood Flow Restriction Training (LL-BFRT) + Aerobic Exercise OTHER

Participants will undergo an 8-week upper extremity aerobic exercise program combined with low-load blood flow restriction training (LL-BFRT). The aerobic exercise will be performed using an arm cycle ergometer at 60-70% of age-predicted maximum heart rate for 20 minutes, preceded and followed by 5 minutes of unloaded cycling. In addition, LL-BFRT will be applied to the proximal upper extremity with a pneumatic cuff at 30-40% of arterial occlusion pressure. Resistance exercises will be performed at 30% of one-repetition maximum (1RM) using a 4-set protocol (30-15-15-15 repetitions) with 45-second inter-set rest periods while maintaining cuff pressure. Target muscles include the biceps brachii, triceps brachii, and anterior deltoid.

Intervention Group

Sham Low-Load Blood Flow Restriction Training (LL-BFRT) + Aerobic Exercise OTHER

Participants will undergo the same 8-week upper extremity aerobic exercise program as the intervention group. Aerobic exercise will be performed using an arm cycle ergometer at 60-70% of age-predicted maximum heart rate for 20 minutes, preceded and followed by 5 minutes of unloaded cycling. In addition, sham blood flow restriction training will be applied with a pneumatic cuff placed proximally on the upper extremity. The cuff pressure will be set at a level insufficient to produce therapeutic blood flow restriction. The exercise structure, sets, repetitions, and muscle groups targeted will be identical to the intervention group.

Control Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 40-80 years with stage 2 and 3 COPD diagnosed according to GOLD criteria
• Clinically stable COPD (no exacerbation in the last 6 weeks)
• Stable medical treatment for at least 4 weeks
• No orthopedic or neurological problems that would prevent them from performing upper extremity exercises
• Resting SpO2 ≥ 88%
• Able to understand and follow verbal instructions in Turkish
• Individuals with a Montreal Cognitive Assessment Scale (MoCa) score ≥ 24 will be included.

You may not qualify if:

• Uncontrolled hypertension
• Severe arrhythmia
• Recent MI
• Deep vein thrombosis
• Peripheral vascular disease
• Presence of infection or open wound
• Having undergone upper extremity surgery within the last 6 months

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Malatya Education and Research Hospital

Malatya, Battalgazi, Turkey (Türkiye)

RECRUITING

Related Publications (25)

• Crum EM, O'Connor WJ, Van Loo L, Valckx M, Stannard SR. Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. Eur J Sport Sci. 2017;17(8):1037-43.

  BACKGROUND

• Huang CT, Ruan SY, Tsai YJ, Chien JY, Yu CJ. Lung fluid content during 6MWT in patients with COPD with and without comorbid heart failure. BMJ Open Respir Res. 2024;11(1).

  BACKGROUND

• Liang WM, Chen JJ, Chang CH, Chen HW, Chen SL, Hang LW, et al. An empirical comparison of the WHOQOL-BREF and the SGRQ among patients with COPD. Qual Life Res. 2008;17(5):793-800.

  BACKGROUND

• Deshpande C, Alaparthi GK, Krishnan S, Chakravarthy Bairapareddy K, Ramakrishna A, Acharya V. Comparison of Londrina activities of daily living protocol and Glittre ADL test on cardio-pulmonary response in patients with COPD: a cross-sectional study. Multidiscip Respir Med. 2020;15(1):694.

  BACKGROUND

• Chamorro C, Arancibia M, Trigo B, Arias-Poblete L, Jerez-Mayorga D. Absolute Reliability and Concurrent Validity of Hand-Held Dynamometry in Shoulder Rotator Strength Assessment: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021;18(17).

  BACKGROUND

• Johanson ME, Lateva ZC, Jaramillo J, Kiratli BJ, McGill KC. Triceps Brachii in Incomplete Tetraplegia: EMG and Dynamometer Evaluation of Residual Motor Resources and Capacity for Strengthening. Top Spinal Cord Inj Rehabil. 2013;19(4):300-10.

  BACKGROUND

• Yeşilyaprak SS, Özden F. An acute bout of foam rolling of the biceps brachii does not affect upper extremity sensorimotor function: a randomized trial. BMC Musculoskelet Disord. 2025;26(1):1044.

  BACKGROUND

• Arne M, Lisspers K, Ställberg B, Boman G, Hedenström H, Janson C, et al. How often is diagnosis of COPD confirmed with spirometry? Respir Med. 2010;104(4):550-6.

  BACKGROUND

• Oncu H, Calik-Kutukcu E, Vardar Yagli N, Inal-Ince D, Saglam M, Unal F, et al. Reliability and validity of the 6-minute pegboard and ring test for functional exercise capacity in patients with breast cancer. Physiother Theory Pract. 2025;41(3):643-55.

  BACKGROUND

• Calik-Kutukcu E, Tekerlek H, Bozdemir-Ozel C, Karaduz BN, Cakmak A, Inal-Ince D, et al. Validity and reliability of 6-minute pegboard and ring test in patients with asthma. J Asthma. 2022;59(7):1387-95.

  BACKGROUND

• Janaudis-Ferreira T, Hill K, Goldstein RS, Wadell K, Brooks D. Relationship and responsiveness of three upper-limb tests in patients with chronic obstructive pulmonary disease. Physiother Can. 2013;65(1):40-3.

  BACKGROUND

• Fabero-Garrido R, Gragera-Vela M, Del Corral T, Hernández-Martín M, Plaza-Manzano G, López-de-Uralde-Villanueva I. Effects of Low-Load Blood Flow Restriction Training on Muscle Anabolism Biomarkers and Thrombotic Biomarkers Compared with Traditional Training in Healthy Adults Older Than 60 Years: Systematic Review and Meta-Analysis. Life (Basel). 2024;14(3).

  BACKGROUND

• Lin Q, Zhang Y, Qin J, Wu F. Effects of Low-Load Blood Flow Restriction Training on Muscle Volume After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2024;12(12):23259671241301731.

  BACKGROUND

• Kohlbrenner D, Kuhn M, Manettas A, Aregger C, Peterer M, Greco N, et al. Low-load blood flow restriction strength training in patients with COPD: a randomised single-blind pilot study. Thorax. 2024;79(4):340-8.

  BACKGROUND

• Pancera S, Lopomo NF, Porta R, Sanniti A, Buraschi R, Bianchi LNC. Effects of Combined Endurance and Resistance Eccentric Training on Muscle Function and Functional Performance in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. Arch Phys Med Rehabil. 2024;105(3):470-9.

  BACKGROUND

• Kohlbrenner D, Aregger C, Osswald M, Sievi NA, Clarenbach CF. Blood-Flow-Restricted Strength Training Combined With High-Load Strength and Endurance Training in Pulmonary Rehabilitation for COPD: A Case Report. Phys Ther. 2021;101(6).

  BACKGROUND

• Panton LB, Golden J, Broeder CE, Browder KD, Cestaro-Seifer DJ, Seifer FD. The effects of resistance training on functional outcomes in patients with chronic obstructive pulmonary disease. Eur J Appl Physiol. 2004;91(4):443-9.

  BACKGROUND

• Gloeckl R, Pitta F, Nyberg A. Optimising upper-limb exercise in patients with COPD: another step towards personalised pulmonary rehabilitation? ERJ Open Res. 2024;10(1).

  BACKGROUND

• Ozsoy I, Ozcan Kahraman B, Ozsoy G, Ilcin N, Kahraman T, Acar S, et al. Determinants of the 6-minute pegboard and ring test as an unsupported upper-extremity exercise capacity measure in older adults with chronic obstructive pulmonary disease. Eur Geriatr Med. 2018;9(6):863-70.

  BACKGROUND

• McKeough ZJ, Velloso M, Lima VP, Alison JA. Upper limb exercise training for COPD. Cochrane Database Syst Rev. 2016;11(11):Cd011434.

  BACKGROUND

• Dag B, Naz İ, Felekoglu E, Emuk Y, Kopruluoglu M, Sahin H. Associations of Upper-Extremity Exercise Capacity and Grip Strength With Cognitive Domains in Patients With COPD. Respir Care. 2024;69(5):595-602.

  BACKGROUND

• Fonseca J, Nellessen AG, Pitta F. Muscle Dysfunction in Smokers and Patients With Mild COPD: A SYSTEMATIC REVIEW. J Cardiopulm Rehabil Prev. 2019;39(4):241-52.

  BACKGROUND

• Wada JT, Borges-Santos E, Porras DC, Paisani DM, Cukier A, Lunardi AC, Carvalho CR. Effects of aerobic training combined with respiratory muscle stretching on the functional exercise capacity and thoracoabdominal kinematics in patients with COPD: a randomized and controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Oct 28;11:2691-2700. doi: 10.2147/COPD.S114548. eCollection 2016.

  PMID: 27822031 BACKGROUND

• Zhang L, Liu Y, Zhao S, Wang Z, Zhang M, Zhang S, et al. The Incidence and Prevalence of Pulmonary Hypertension in the COPD Population: A Systematic Review and Meta-Analysis. Int J Chron Obstruct Pulmon Dis. 2022;17:1365-79.

  BACKGROUND

• Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, et al. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017;195(5):557-82.

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Zeynal Yasacı, Doctor Lecturer

CONTACT

+905075409791; zeynal.yasaci@inonu.edu.tr

Emine Tonak

CONTACT

+905372994319; eminetonak4006@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is designed as a single-blind randomized controlled trial. Participants will be blinded to group allocation. Both the intervention (LL-BFRT) and control (sham-BFRT) groups will receive identical exercise protocols in terms of frequency, duration, targeted muscle groups, and set-repetition structure. In the sham-BFRT group, cuff pressure will be applied at a level insufficient to produce therapeutic blood flow restriction. Participants will not be informed whether the applied cuff pressure represents an active or sham intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Lecturer

Model Details: Participants will be randomly assigned to one of two parallel groups: (1) an intervention group receiving aerobic exercise combined with low-load blood flow restriction training (LL-BFRT), or (2) a control group receiving aerobic exercise combined with sham blood flow restriction training (sham-BFRT). Both groups will follow the same exercise frequency, duration, and protocol structure over an 8-week period. Outcomes will be compared between groups to determine the additional effects of LL-BFRT on upper extremity muscle strength, functional capacity, and related clinical parameters in individuals with stage II-III COPD.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 13, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)