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

NCT01354067 | Completed

• 1 other identifier: LHM-2011-ANKW
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

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

• 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.

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

• Upper extremity muscular endurance

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

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

Secondary Outcomes (12)

• Isokinetic maximal muscle strength

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

• Upper extremity muscular endurance

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

• Isokinetic muscular endurance capacity

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

• Self-efficacy

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

• Anxiety and Depression

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

Study Arms (2)

Control group

ACTIVE COMPARATOR

The control group will receive standardized patient education four times, once every two weeks, during the eight week intervention period.

Behavioral: Control group

High-repetitive single limb training

EXPERIMENTAL

The 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.

Behavioral: High-repetitive single limb training

Interventions

Control group BEHAVIORAL

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.

Control group

High-repetitive single limb training BEHAVIORAL

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.

High-repetitive single limb training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (2)

Huddinge University Hospital

Huddinge, 141 59, Sweden

Location

Umeå University Hospital

Umeå, 90187, Sweden

Location

Related Publications (1)

• 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.

  PMID: 22823966 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Karin Wadell, Ph.D

  Umeå University

  PRINCIPAL INVESTIGATOR

• Andre Nyberg, Msc

  Umeå University

  STUDY CHAIR

• Britta Lindström, Ph.D

  Umeå University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 16, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

SE (2)