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Pulmonary Disease, Chronic ObstructiveCOPDNCT01354067

Single Limb Resistance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A study testing High-repetitive single limb training in people with Pulmonary Disease, Chronic Obstructive, run by Umeå University at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
High-repetitive single limb training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesSweden
Study dates
May 2011to Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults 40 years and above.
  • 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.
  • Ex-smoker.
  • Stable medical treatment (no changes < 4 weeks before start of baseline testing).
  • Living less than 60 km from training facility.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites
  • Huddinge University Hospital

    Huddinge, 141 59

  • Umeå University Hospital

    Umeå, 90187

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Control group, High-repetitive single limb training
Keywords
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Single Limb, Elastic Resistance, Resistance Training, Minor Muscle Mass, Local muscle training
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupBehavioural

    The control group receives standardized patient education four times, once every two weeks, during the eight week intervention period. Each session will last 60 minutes, consisting of information regarding anatomy, physiology, causes and mechanisms of COPD, drugs, nutrition, aids and energy saving procedures. The information is the same as for the intervention group, given at separate occasions.

  • High-repetitive single limb trainingBehavioural

    The high-repetitive single limb exercise regime consists of three sessions per week during eight weeks of exercise training, giving a total number of 24 sessions at each location (Umeå and Huddinge University hospitals). The exercise sessions are supervised and conducted by a physical therapist using a group format, six to eight participants in each group. Each session will span for 60 minutes, duration of the major components are: 10 min warm-up followed by 40 minutes of single limb training and 10min cool-down. In addition this experimental group also receives four sessions of patient education once every two week.

Study groups in NCT01354067
Study groupRoleWhat they receive
Control groupActive comparatorThe control group will receive standardized patient education four times, once every two weeks, during the eight week intervention period.
Receives: Behavioral: Control group
High-repetitive single limb trainingExperimentalThe experimental group will receive a high-repetitive single limb exercise regime, three times a week for two months. In addition, the exercise group will receive patient education at four occasions during the intervention period.
Receives: Behavioral: High-repetitive single limb training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life

    The Swedish Self-Administered Standardized version of the Chronic Respiratory Disease Questionnaire (CRQ-SAS) will be used as primary outcome measure to asses quality of life

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  2. Functional lower extremity muscular endurance

    To asses muscular endurance in the lower extremity the 6-minute walk test will be used as primary outcome measure.

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  3. Upper extremity muscular endurance

    The 6-minute ring and pegboard test will be used as primary outcome measure for upper extremity muscular endurance

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

Secondary outcomes (12)
  1. Isokinetic maximal muscle strength

    Maximal muscle strength in both upper and lower extremity will be evaluated with an isokinetic dynamometer

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  2. Upper extremity muscular endurance

    The Unsupported Upper Limb Exercise test will be used as secondary outcome measure for upper extremtiy muscular endurance

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  3. Isokinetic muscular endurance capacity

    Endurance capacity in both upper and lower extremity will be evaluated with an isokinetic dynamometer

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  4. Self-efficacy

    Self-efficacy will be evaluated with the exercise self-efficacy scale, and the self-efficacy for walking questionnaire

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  5. Anxiety and Depression

    Anxiety and Depression will be evaluated with the hospital anxiety and depression scale (HADs)

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  6. Relationship between muscle fatigue and dyspnea in the different exercise tests

    Muscle fatigue and dyspnea will be measured using the BORG CR10 scale during all exercise tests before the start of the study and on completion 8 weeks later. The relationship between ratings of muscle fatigue between tests, dyspnea between tests and the relationship between muscle fatigue rating and dyspnea rating between exercise tests will be investigated.

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  7. Develop a strategy to optimize resistance for each involved movement within an exercise regimen

    The exercises used within the intervention group is performed with elastic resistance. How much the elastic band is stretched for the different exercises is determined by a literature search investigation the strenght relationship between the muscles/movements used in the study. During the study each participant in the intervention group will rate muscle fatigue and dyspnea after each exercise during alla exercise sessions. These rating will be used to develop a strategy to optimize resistance for each involved movement within an exercise regimen

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  8. Develop a strategy to minimize attempts needed to determine a multiple repetition resistance using elastic bands

    55% of the isokinetic peak value obtained during baseline tests will be used to anticipate the 25RM load when using elastic resistance in an attempt to minimize the attempts needed to achieve 25RM.

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  9. Determine if this exercise regimen is feasible and safe in stage II-IV COPD patients

    Feasibility will be evaluated through number of participants attendance, adherence and number of participants developing any side effects or injuries during each training session. In addition, compliance to the different parts of the exercise regimen will be evaluated with a standardized questionnaire by both study participants and physiotherapists leading interventions.

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  10. Identify if there are any sex related differences in exercise training effects

    Statistical analyzes will be used to identify if there are any sex related differences in exercise training effects between male and female patients with COPD

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  11. Quality-of-life

    The clinical COPD questionnaire (CCQ) and the SF-36 scale will be used as secondary outcome measures for Quality-of-life

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

  12. Exercise capacity

    A constant work rate test investigating the effects on endurance time, ventilatory response, perceived dyspnea and leg fatigue during submaximal cycle test.

    Measured: Before single limb exercise regime and on completion (at 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01354067
Sponsor's protocol ID
LHM-2011-ANKW
Acronym
COPD
Status last verified
Jun 2012
First submitted
11 May 2011
Last updated
21 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22823966

Questions about this trial

What is this clinical trial studying?

A study testing High-repetitive single limb training in people with Pulmonary Disease, Chronic Obstructive, run by Umeå University at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (time frame: Before single limb exercise regime and on completion (at 8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01354067, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.

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