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Study on Impact of Maximal Strength Training in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Maximal strenght training (MST) plus endurance training (ET)
Endurance training (ET)
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring rehabilitation, resistive training, exercise

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of LumezzaneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control group

Arm Description

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

Endurance training (ET)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Leg Strength by 1-Repetition Maximum on leg press
1-Repetition Maximum (1RM) will be evaluated. 1RM will be measured on a horizontal leg press at a knee angle of 90°. 1RM will be recorded as the heaviest lifted load achieved, applying rest periods of ~4 min between test lifts and increments of 5 kg between each trial until failure.
Change in maximal Rate of Force Development (RFD)
Immediately after the maximal test 1-RM (see above), using the same apparatus, maximal rate of Force Development (RFD) will be assessed using a force platform and applying a load corresponding to 75% of the participant's pre-test 1RM. The subjects will be instructed to execute the lift as rapidly as possible in the concentric phase. RFD will be analyzed as the time difference between 10% and 90% of Peak force.
Change in maximal effort tolerance
It will be evaluated by VO2 consumption on maximal cardiopulmonary exercise test (CPET) on cycloergometer
Change in Constant Load Effort tolerance
It will be evaluated by evaluated by time of execution of Cardiopulmonary Constant-Load Endurance Test
Change in Fatigue (physiological evaluation)
To define peripheral and central component of fatigue, before and after CLET, the investigators will test the difference on force produced during a single twitch superimposed on the Maximal Voluntary Contraction (MVC) and the force produced by the electrically evoked Resting Twitch (RT) produced, at rest, 5 seconds after the MVC.
Change in Fatigue (qualitative evaluation)
Fatigue Severity Scale (scale measuring fatigue, 9-item scale ranging from 7 = absence of fatigue to 63= maximal presence of fatigue)
Change in Muscle volume
Sagittal ultrasound images of the Vastus Lateralis (VL) muscle will be recorded with an 8-12 MHz linear transducer. Images will be obtained with a 90° flexion of hip and knee, at 50% of femur length. The pennation angle (hp) of the VL fascicles will be measured as the angle between the VL muscle fascicles and the deep aponeurosis of the insertion.
Change in Dyspnea
Barthel Index Dyspnea (scale measuring dyspnea during basal ADL, 10-item scale ranging from 0 = absence of dyspnea to 100 = maximal dyspnea)
Concentration of CRP
C reactive protein [CRP] (mg/dl)
Change in Low grade Inflammation
Evaluation of neutrophils/ lymphocytes ratio
Concentration of Tumor necrosis factor alpha
TNF-alpha (pg/ml)
Concentration of Interleukin-6
IL6 (pg/ml)
Muscular proteolyses by 3-MeH concentration
Evaluation of urinary 3 Methyl-Histine (3-MeH) (micromol/ml)
Change in Balance (qualitative measure)
BERG scale ( scale measuring balance, composed by 14 balance related tasks, ranging from 0 = worse balance to 56= best balance)
Change in quality of life
EuroQol 5-D (scale measuring quality of life, composed by 2 sessions: one of 5 questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with multiple choice ranging from 0 = no problem to 25= very low quality of life and one using Visual Analogic Scale (VAS) to quantify the health status ranging from 0 = worst health condition to 100 = best health condition. The two scale sessions are considered separately.
Patient Satisfaction: Likert Scale
Likert Scale 0-4 ( 0=completely unsatisfied, 4= very satisfied).
Change in Falls
Evaluation of the rate of falls
Hospitalizations
Evaluation of the rate of hospitalizations
Mortality
Evaluation of deaths (number)
Change in Balance (quantitative measure)
The fall risk (FR) assessment will be evaluated by Balance Board.

Full Information

First Posted
December 4, 2018
Last Updated
September 27, 2023
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Universita di Verona
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1. Study Identification

Unique Protocol Identification Number
NCT03799354
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Universita di Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
rehabilitation, resistive training, exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Maximal strenght training (MST) plus endurance training (ET)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Endurance training (ET)
Intervention Type
Other
Intervention Name(s)
Maximal strenght training (MST) plus endurance training (ET)
Intervention Description
Patients will perform an addictive out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions) consisting of: 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. 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.
Intervention Type
Other
Intervention Name(s)
Endurance training (ET)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in walking efficiency
Description
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.
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Leg Strength by 1-Repetition Maximum on leg press
Description
1-Repetition Maximum (1RM) will be evaluated. 1RM will be measured on a horizontal leg press at a knee angle of 90°. 1RM will be recorded as the heaviest lifted load achieved, applying rest periods of ~4 min between test lifts and increments of 5 kg between each trial until failure.
Time Frame
baseline and 8 weeks
Title
Change in maximal Rate of Force Development (RFD)
Description
Immediately after the maximal test 1-RM (see above), using the same apparatus, maximal rate of Force Development (RFD) will be assessed using a force platform and applying a load corresponding to 75% of the participant's pre-test 1RM. The subjects will be instructed to execute the lift as rapidly as possible in the concentric phase. RFD will be analyzed as the time difference between 10% and 90% of Peak force.
Time Frame
baseline and 8 weeks
Title
Change in maximal effort tolerance
Description
It will be evaluated by VO2 consumption on maximal cardiopulmonary exercise test (CPET) on cycloergometer
Time Frame
baseline and 8 weeks
Title
Change in Constant Load Effort tolerance
Description
It will be evaluated by evaluated by time of execution of Cardiopulmonary Constant-Load Endurance Test
Time Frame
baseline and 8 weeks
Title
Change in Fatigue (physiological evaluation)
Description
To define peripheral and central component of fatigue, before and after CLET, the investigators will test the difference on force produced during a single twitch superimposed on the Maximal Voluntary Contraction (MVC) and the force produced by the electrically evoked Resting Twitch (RT) produced, at rest, 5 seconds after the MVC.
Time Frame
baseline and 8 weeks
Title
Change in Fatigue (qualitative evaluation)
Description
Fatigue Severity Scale (scale measuring fatigue, 9-item scale ranging from 7 = absence of fatigue to 63= maximal presence of fatigue)
Time Frame
baseline and 8 weeks
Title
Change in Muscle volume
Description
Sagittal ultrasound images of the Vastus Lateralis (VL) muscle will be recorded with an 8-12 MHz linear transducer. Images will be obtained with a 90° flexion of hip and knee, at 50% of femur length. The pennation angle (hp) of the VL fascicles will be measured as the angle between the VL muscle fascicles and the deep aponeurosis of the insertion.
Time Frame
baseline and 8 weeks
Title
Change in Dyspnea
Description
Barthel Index Dyspnea (scale measuring dyspnea during basal ADL, 10-item scale ranging from 0 = absence of dyspnea to 100 = maximal dyspnea)
Time Frame
baseline and 8 weeks
Title
Concentration of CRP
Description
C reactive protein [CRP] (mg/dl)
Time Frame
baseline and 8 weeks
Title
Change in Low grade Inflammation
Description
Evaluation of neutrophils/ lymphocytes ratio
Time Frame
baseline and 8 weeks
Title
Concentration of Tumor necrosis factor alpha
Description
TNF-alpha (pg/ml)
Time Frame
baseline and 8 weeks
Title
Concentration of Interleukin-6
Description
IL6 (pg/ml)
Time Frame
baseline and 8 weeks
Title
Muscular proteolyses by 3-MeH concentration
Description
Evaluation of urinary 3 Methyl-Histine (3-MeH) (micromol/ml)
Time Frame
baseline and 8 weeks
Title
Change in Balance (qualitative measure)
Description
BERG scale ( scale measuring balance, composed by 14 balance related tasks, ranging from 0 = worse balance to 56= best balance)
Time Frame
baseline and 8 weeks
Title
Change in quality of life
Description
EuroQol 5-D (scale measuring quality of life, composed by 2 sessions: one of 5 questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with multiple choice ranging from 0 = no problem to 25= very low quality of life and one using Visual Analogic Scale (VAS) to quantify the health status ranging from 0 = worst health condition to 100 = best health condition. The two scale sessions are considered separately.
Time Frame
baseline and 8 weeks
Title
Patient Satisfaction: Likert Scale
Description
Likert Scale 0-4 ( 0=completely unsatisfied, 4= very satisfied).
Time Frame
at 8 weeks
Title
Change in Falls
Description
Evaluation of the rate of falls
Time Frame
baseline and 8 months
Title
Hospitalizations
Description
Evaluation of the rate of hospitalizations
Time Frame
baseline and 8 months
Title
Mortality
Description
Evaluation of deaths (number)
Time Frame
baseline and 8 months
Title
Change in Balance (quantitative measure)
Description
The fall risk (FR) assessment will be evaluated by Balance Board.
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mara Paneroni, MSc, PT
Phone
0039+030+8253
Ext
122
Email
mara.paneroni@icsmaugeri.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Baiardi, Math
Phone
0039+0382+592
Ext
599
Email
paola.baiardi@icsmaugeri.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara Paneroni, MSc, PT
Organizational Affiliation
Istituti Clinici Scientifici Maugeri
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane
City
Lumezzane
State/Province
Brescia
ZIP/Postal Code
25065
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mara Paneroni, MSc, PT
Phone
0039+030+8253
Ext
122
Email
mara.paneroni@icsmaugeri.it
First Name & Middle Initial & Last Name & Degree
Michele Vitacca, MD
Phone
0039+030+8253
Ext
182
Email
michele.vitacca@icsmaugeri.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24787074
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.
Results Reference
background
PubMed Identifier
10378915
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.
Results Reference
background
PubMed Identifier
17277584
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.
Results Reference
background
PubMed Identifier
19804581
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.
Results Reference
background

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Study on Impact of Maximal Strength Training in Patients With COPD

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