Clinical trial NCT03799354: Study on Impact of Maximal Strength Training in Patients With COPD
Official title: Study on Impact of Maximal Strength Training in Patients With COPD: Physiological and Clinical Implications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: rehabilitation
resistive training
exercise
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Universita di Verona
First posted: 2019-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled trial
Primary purpose: OTHER

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).

Detailed description: Exercise intolerance is a cardinal problem existing in patients with Chronic Obstructive Pulmonary Disease (COPD). Moreover, skeletal muscle dysfunction is a common extra-pulmonary manifestation, leading to fatigue, decrease in activity of daily living (ADL) performance and quality of life and increase of risk of falls, mainly in older patients. In the context of pulmonary rehabilitation, 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.

As concern the RT programs, metanalysis in COPD describe that training have been mainly performed with the lower limbs and the training intensities are heterogeneous, generally ranging from 40% to 70% of 1-Repetition Maximum (1-RM).

Maximal Strength Training (MST) is a 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.

Although the mechanisms at the base of MST effect on the mechanical efficiency have not been completely clarified, there is evidence that changes in the relationships between power and speed bring to a longer relaxation phase inside the cycle of job, improving the recovery between contractions.

In this field, only a small cohort study of COPD patients was conducted describing that MST can meaningfully improve the strength and the 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. Nevertheless, this study has been conducted only in a small cohort (twelve patients) of patients with COPD and further studies are necessary to define the impact on the different components that determine the effort intolerance.

The main aim of this physiological pilot randomized controlled trail will be to test the feasibility and the 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in walking efficiency
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change in Leg Strength by 1-Repetition Maximum on leg press
timeFrame: baseline and 8 weeks
measure: Change in maximal Rate of Force Development (RFD)
timeFrame: baseline and 8 weeks
measure: Change in maximal effort tolerance
timeFrame: baseline and 8 weeks
measure: Change in Constant Load Effort tolerance
timeFrame: baseline and 8 weeks
measure: Change in Fatigue (physiological evaluation)
timeFrame: baseline and 8 weeks
measure: Change in Fatigue (qualitative evaluation)
timeFrame: baseline and 8 weeks
measure: Change in Muscle volume
timeFrame: baseline and 8 weeks
measure: Change in Dyspnea
timeFrame: baseline and 8 weeks
measure: Concentration of CRP
timeFrame: baseline and 8 weeks
measure: Change in Low grade Inflammation
timeFrame: baseline and 8 weeks
measure: Concentration of Tumor necrosis factor alpha
timeFrame: baseline and 8 weeks
measure: Concentration of Interleukin-6
timeFrame: baseline and 8 weeks
measure: Muscular proteolyses by 3-MeH concentration
timeFrame: baseline and 8 weeks
measure: Change in Balance (qualitative measure)
timeFrame: baseline and 8 weeks
measure: Change in quality of life
timeFrame: baseline and 8 weeks
measure: Patient Satisfaction: Likert Scale
timeFrame: at 8 weeks
measure: Change in Falls
timeFrame: baseline and 8 months
measure: Hospitalizations
timeFrame: baseline and 8 months
measure: Mortality
timeFrame: baseline and 8 months
measure: Change in Balance (quantitative measure)
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane
state: Brescia
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri
name: Mara Paneroni, MSc, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.