Study on Impact of Maximal Strength Training in Patients With COPD

NCT03799354 | Recruiting

• 1 other identifier: ICS Maugeri CE 2241
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events. Maximal Strength Training (MST) is a kind of RT typically performed at \~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations. When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency. Only a small cohort study of COPD patients was conducted, describing that MST can meaningfully improve strength and RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. The main aims of this physiological pilot randomized controlled trail will be to evaluate feasibility and efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

rehabilitation; resistive training; exercise

Outcome Measures

Primary Outcomes (1)

• Change in walking efficiency

  The text will be executed using a portable metabolimeter detecting oxygen consumption (VO2). After a 10 min of warm up on a treadmill, the patient will walk 5 min at submaximal steady state walking at 4.5 km/h at 5% incline. Using the average of VO2 of the last minute of walking, the walking efficiency will be defined as percentage of change as follows: external work accomplished/ energy expenditure x 100.

  baseline and 8 weeks

Secondary Outcomes (20)

• Change in Leg Strength by 1-Repetition Maximum on leg press

  baseline and 8 weeks

• Change in maximal Rate of Force Development (RFD)

  baseline and 8 weeks

• Change in maximal effort tolerance

  baseline and 8 weeks

• Change in Constant Load Effort tolerance

  baseline and 8 weeks

• Change in Fatigue (physiological evaluation)

  baseline and 8 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

Maximal strenght training (MST) plus endurance training (ET)

Other: Maximal strenght training (MST) plus endurance training (ET)

Control group

ACTIVE COMPARATOR

Endurance training (ET)

Other: Endurance training (ET)

Interventions

Maximal strenght training (MST) plus endurance training (ET) OTHER

Patients will perform an addictive out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions) consisting of: 1. MST- It will consist of four sets of five repetitions on a leg-press with a focus on the rate of force development during the concentric contraction of the quadriceps from a 90° to legs complete extension. The load will be 85-90% of 1RM. When a patient will be able to perform more than five repetitions in a set, the load will be increased. All strength training will be performed on a seated horizontal leg press. 2. ET - A cycling session will follow the MST and last 40 minutes at constant-load, starting from a load intensity corresponding to patient specific AT. The intensity will be gradually increased with a symptom-based progression.

Treatment Group

Endurance training (ET) OTHER

Patients will perform a usual out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions). They will perform ET by cycling sessions that will last 40 minutes/each at constant-load, starting from a load intensity corresponding to patient specific AT, assessed during the baseline incremental test. The intensity will be gradually increased during the sessions with a symptom-based progression, according to the protocol by Maltais and coworkers. A 3-min warm-up and cool-down will be provided. Heart rate (HR), blood pressure, oxygen pulsoxymetry, and symptoms by Borg CR10 scale will be monitored at the beginning and end of each session. Out of the training-days, both groups will continue their normal daily living with modest regular activity, as recommended by their physician.

Control group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) \< 70%, and FEV1 \< 50% of predicted
• stable clinical condition

You may not qualify if:

• pulmonary diseases other than COPD
• type II diabetes or other metabolic diseases
• malign disease
• a respiratory tract infection within the last 4 wks
• long oxygen therapy use.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Universita di Verona: collaborator

Study Sites (1)

ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane

Lumezzane, Brescia, 25065, Italy

RECRUITING

Related Publications (4)

• Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.

  PMID: 24787074 BACKGROUND

• Hoff J, Helgerud J, Wisloff U. Maximal strength training improves work economy in trained female cross-country skiers. Med Sci Sports Exerc. 1999 Jun;31(6):870-7. doi: 10.1097/00005768-199906000-00016.

  PMID: 10378915 BACKGROUND

• Hoff J, Tjonna AE, Steinshamn S, Hoydal M, Richardson RS, Helgerud J. Maximal strength training of the legs in COPD: a therapy for mechanical inefficiency. Med Sci Sports Exerc. 2007 Feb;39(2):220-6. doi: 10.1249/01.mss.0000246989.48729.39.

  PMID: 17277584 BACKGROUND

• Wang E, Helgerud J, Loe H, Indseth K, Kaehler N, Hoff J. Maximal strength training improves walking performance in peripheral arterial disease patients. Scand J Med Sci Sports. 2010 Oct;20(5):764-70. doi: 10.1111/j.1600-0838.2009.01014.x.

  PMID: 19804581 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mara Paneroni, MSc, PT

  Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara Paneroni, MSc, PT

CONTACT

0039+030+8253; mara.paneroni@icsmaugeri.it

Paola Baiardi, Math

CONTACT

0039+0382+592; paola.baiardi@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomized controlled trial

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: January 10, 2019
• Study Start: September 18, 2019
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)