Clinical trial NCT01354067: Single Limb Resistance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Effects of High-repetitive Single Limb Training on Exercise Capacity and Quality of Life in Patients With COPD Compared to a Control Group - A Prospective, Single Blind, Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Single Limb
Elastic Resistance
Resistance Training
Minor Muscle Mass
Local muscle training
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The chronic airflow limitation in chronic obstructive pulmonary disease (COPD) patients resulting in increased dyspnea during physical activity restricts many COPD patients ability to perform exercises in general and whole-body exercises in particular. Single limb training performed as one-legged cycling has been shown effective in patients with COPD. This exercise regime results in less stress on the ventilatory system as training is executed using a simultaneously smaller muscle mass. However, the positive physiological effects of exercise training only occur in the involved muscle(s). To be of benefit for patients daily life, all relevant muscles should be included in exercise training. The aim of the current randomized controlled multicenter trial (RCT) is to determine the effects of high-repetitive single limb exercises (HRSLE) in combination with COPD specific patient education, compared to the COPD specific patient education alone in patients with moderate to very severe (stage II-IV) COPD.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a major cause of chronic morbidity and mortality in the world. It is one of our most common chronic diseases and up to 700.000 people is estimated to suffer from COPD in Sweden. Exercise intolerance is the key disabling factor in COPD, with decreased exercise capacity, leg fatigue and dyspnea among the most frequently reported symptoms.

Different training modalities have been evaluated to uncover the most effective way of training patients with COPD. Traditionally research has used whole-body, or major muscle mass training regimes when investigating the effect of both endurance and resistance in COPD patients. However recent research have demonstrated positive effects using training regimes involving a simultaneous smaller muscle mass compared to traditional exercise. The concept of using this regime is to put less stress on the ventilator system when exercising to minimize the effect of the chronic airflow limitation and to enhance the ability to be able to exercise for this group of patients compared to traditional training using major muscle mass exercise regimes. Although recent research have shown positive effects of single limb training using one-legged cycling, one major limitation is that only a small amount of important muscles for COPD patients are incorporated. Therefore, the aim of this study is to: (i) examine the effect of a single limb exercise regime on local muscle endurance, maximal strength, quality of life, dyspnea, walking capacity, self-efficacy, anxiety and depression, (ii) to examine if the physiological effects differ between man and women and (iii) to investigate if this exercise regime is feasible and safe to use for patients with COPD.

Patients diagnosed with moderate to very severe COPD according to GOLD criteria will be randomly assigned to constitute either an exercise or control group The exercise group will participate in a high-repetitive single limb exercise regime, consisting of upper and lower limb exercises with elastic resistance, compromised of three sessions per week over a period of 8 weeks. The exercise regime will be performed in group at Umeå University Hospital of Northern Sweden, and at Huddinge University Hospital, Sweden supervised by experienced physiotherapists. Both the exercise and control group will receive four sessions of standardized patient education during the 8 week intervention period. After completion of the study, patients in the control group will be offered participation in the single limb exercise regime.

The most important upper and lower extremity muscles for COPD patients are identified and exercises are designed specific to each of these. The exercise regime consists of 8 exercises, 4 upper extremity and 4 lower extremity exercises. Starting position and performance of the exercises are standardized and the resistance individually adjusted and progressed according to rated dyspnea and muscle fatigue.

Before and after the 8 week intervention period the following information will be collected. Effects on maximal strength, muscular endurance, dyspnea, self-efficacy, anxiety and depression. The relationship between changes in health related variables and changes in exercise capacity, sex related differences in training effects, feasibility of the program, strategies to determine adequate starting resistance and provide accurate resistance for each involved movement and the relationship between muscle fatigue and dyspnea in the different exercise tests will also be analyzed.

Eligibility criteria: Inclusion Criteria:

1. Adults 40 years and above.
2. Stable (no exacerbations within 4 weeks before start of baseline testing) moderate to very severe COPD, stage II-IV, according to GOLD criteria i.e. Forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) \< 0.70, FEV1 \< 80% predicted.
3. Ex-smoker.
4. Stable medical treatment (no changes \< 4 weeks before start of baseline testing).
5. Living less than 60 km from training facility.

Exclusion Criteria:

1. Musculoskeletal, rheumatic, cardiac or neurological disorders that might affect the exercise performance in training and tests.
2. Previous lung surgery.
3. Acute exacerbations of COPD that require a change in pharmacological management within four weeks preceding the start of the intervention
4. Long-term oxygen treatment.
5. Participated in organized exercise training, \> 2 times a week, within 6 months before start of intervention.
6. Body mass index (BMI) \< 18 kg/m2.

Primary outcomes:
measure: Quality of life
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Functional lower extremity muscular endurance
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Upper extremity muscular endurance
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
Secondary outcomes:
measure: Isokinetic maximal muscle strength
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Upper extremity muscular endurance
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Isokinetic muscular endurance capacity
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Self-efficacy
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Anxiety and Depression
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Relationship between muscle fatigue and dyspnea in the different exercise tests
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Develop a strategy to optimize resistance for each involved movement within an exercise regimen
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Develop a strategy to minimize attempts needed to determine a multiple repetition resistance using elastic bands
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Determine if this exercise regimen is feasible and safe in stage II-IV COPD patients
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Identify if there are any sex related differences in exercise training effects
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Quality-of-life
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
measure: Exercise capacity
timeFrame: Before single limb exercise regime and on completion (at 8 weeks)
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Huddinge University Hospital
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Karin Wadell, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Andre Nyberg, Msc
role: STUDY_CHAIR
affiliation: Umeå University
name: Britta Lindström, Ph.D
role: STUDY_CHAIR
References:
citation: Nyberg A, Lindstrom B, Wadell K. Assessing the effect of high-repetitive single limb exercises (HRSLE) on exercise capacity and quality of life in patients with chronic obstructive pulmonary disease (COPD): study protocol for randomized controlled trial. Trials. 2012 Jul 23;13:114. doi: 10.1186/1745-6215-13-114.