Effect and Feasibility of Non-linear Periodized Resistance Training in People With COPD

Change from baseline static maximal endurance at week 9

Maximal limb muscle endurance measured using a computerized dynamometer or strain gauge. Reported in seconds maintaining 60% of the isometric maximal voluntary contraction.

Time frame: Baseline and week 9

Change from baseline static maximal strength at week 9

Maximal limb muscle strength measured using a computerized dynamometer or strain gauge. Reported in Nm

Time frame: Baseline and week 9

Change from baseline unsupported upper limb test (UULEX) at week 9

The UULEX is a progressive test where the participants will be asked to a raise plastic bar from the hip to the UULEX eight-level chart with a cadence of 30 movements per minute. If a patient reaches the highest level, the plastic bar will be replaced by a heavier one every minute. There are five different bar weights (0.2, 0.5, 1, 1.5, 2 Kg) and participants will continue on the highest level until symptom limitation. Results are reported in seconds.

Time frame: Baseline and week 9

Change from baseline endurance shuttle walk test (ESWT) at week 9

The ESWT is a derivative of the Incremental shuttle walk test (ISWT), where patients walk for as long as possible at a predetermined percentage of maximum walking performance as assessed by the ISWT on a 10 meter course. Reported in seconds to termination of the test or total meters walked.

Time frame: Baseline and week 9

Change from baseline 60 seconds sit to stand test (60STS) at week 9

During the 60STS, participants will be instructed to fully stand up and sit down as fast as possible, as many times as possible within 60 seconds. Arms will be held fold across the chest with feet remaining in full contact with the floor. Reported as the number of repetitions performed within 60 seconds.

Time frame: Baseline and week 9

Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Total Scores at week 9

The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rates their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items are equally weighted, and total score ranges from 20 to 140 (20 maximum impairment, 140 no impairment).

Time frame: Baseline and week 9

Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) dyspnea Domain Scores at week 9

Domain scores are calculated as the mean of all items (5) within the dyspnea domain. Participants rates their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items are equally weighted, and total score ranges from 7 to 35 (7 maximum dyspnea, 35 no dyspnea).

Time frame: Baseline and week 9

Number of responders

The total amount of responders i.e. defined as a response over the known minimal detectable change/or minimal important difference for included test(s) will be determined and compared.

Time frame: Week 9

Attendance rate

Attendance rate will be evaluated by calculating the number of attended sessions divided by total number of sessions for each participant

Time frame: Week 1 up to 8

Duration of exercise sessions

Mean time in minutes of exercise sessions

Time frame: Week 1 up to 8

Satisfaction rate

Participant satisfaction with the exercise regimens will be recorded by adapting an existing patient satisfaction questionnaire. Participants rate their satisfaction on 7 items each with a 5 point likert scale. Results using the total score (0-35, higher score indicating higher satisfaction).

Time frame: Week 9

Proportion of drop-outs

Proportion of participants that don't complete the intervention

Time frame: Week 9

Adverse Events rate

Occurrence of any adverse events. An adverse event rate will be calculated for each patient as the total number of sessions during which any adverse events occurred divided by the total number of attended sessions.

Time frame: Week 1 up to 8

Adverse Events stratified by severity

The severity of the adverse events will be assessed and rated into four different categories: 1) minor and temporary, 2) serious symptoms (potential risk of severe injury or life threatening), 3) manifest injury or disease, and 4) death. Presented in factual numbers for each group.

Time frame: Week 1 up to 8

Change from baseline muscle fiber size at week 9

The tissue sample obtained from the vastus lateralis muscle will be examined with morphometric analyses to determine cross-sectional fiber area. Reported in square micrometers.

Time frame: Baseline and week 9

Change from baseline proportion of slow and fast subtypes of contractile myosin heavy chain isoforms in fibers at week 9

The tissue sample obtained from the vastus lateralis muscle will be examined with immunohistochemistry techniques to categorize fiber types.

Time frame: Baseline and week 9

Change from baseline oxidative (citrate synthase (CS), EC 4.1.3.7) enzyme activities at week 9

The tissue sample obtained from the vastus lateralis muscle will be examined to demonstrate enzyme activities. Reported in micromol/min/g tissue. \[Time Frame: Baseline and week 9\] The tissue sample obtained from the vastus lateralis muscle will be examined by histochemistry to demonstrate enzyme activities. Reported in micromol/min/g tissue.

Time frame: Baseline and week 9

Change from baseline glycolytic (lactate dehydrogenase (LDH), EC 1.1.1.27) enzyme activities at week 9

The tissue sample obtained from the vastus lateralis muscle will be examined to demonstrate enzyme activities. Reported in micromol/min/g tissue.

Time frame: Baseline and week 9

Change from baseline capillarization (capillary density) at week 9

The tissue sample obtained from the vastus lateralis muscle will be examined with morphometric analysis to determine capillary density, estimated as the total number of capillaries per millimeter squared muscle cross-section.

Time frame: Baseline and week 9

Change from baseline capillarization (capillaries to fiber) at week 9

The tissue sample obtained from the vastus lateralis muscle will be examined with morphometric analysis to determine the number of capillaries around fibers including all capillaries in contact with each muscle fiber.

Time frame: Baseline and week 9

Change from baseline capillarization (capillaries relative to fiber area) at week 9

The tissue sample obtained from the vastus lateralis muscle will be examined with morphometric analysis to determine the number of capillaries around each fiber relative to its cross-sectional area.

Time frame: Baseline and week 9