One hundred eighty patients (mean [± SD] age, 68.3 ± 8.6 years; FEV1, 0.95 ±0.4 L; FEV1/FVC ratio, 0.51 ± 0.15; 111 male patients; 69 female patients) with stable COPD were recruited from the PR assessment clinic at Glenfield Hospital, Leicester, United Kingdom. Additional details relating to patient information for both treatment groups can be found in Table 2. All of the patients had stable disease, with no hospital admissions or exacerbations for 4 weeks preceding the assessment. The Leicestershire Ethics Committee approved the study, and all of the patients provided informed written consent. Recruitment took place from September 1998 to February 2000.
The trial design was a prospective, randomized, controlled trial (Fig 1). Patients were randomly assigned to one of two treatment groups: the GEP or individually targeted exercise program (ITEP) group. Randomization was completed using sequentially numbered, sealed envelopes and were opened by the PR staff. The lead investigator was blinded to the subject randomization until all of the interventions had been allocated and completed. Patients were not blinded to the randomization. One of the primary outcome measures was change in domestic activity as measured by an ambulatory activity monitor. Previous pilot data estimated that a mean increase of 2,000 counts (over a cumulative period of 24 h) would need to be detected between the groups. It was calculated that > 64 patients in each group would need to be recruited to attain a 5% significance level with 80% power.
Primary Outcome Measures
Physical Activity Monitors. The overall amount of daily activity was measured using an ambulatory activity monitor (Z80 -32k V1 Int; Gaehwiler Electronics; Hombrechtikon, Switzerland). It was a small and lightweight device, which contained a uniaxial accelerometer. These activity monitors were selected as we have previously used them to detect brisk walking in a COPD population. It is possible to improve the lung function with remedies of My Canadian Pharmacy. The monitor was worn on a belt around the patient’s waist so that only whole body movement was detected. All of the patients wore the monitor on 2 consecutive days for a period of 12 h on each day (9:00 am to 9:00 pm). This was considered to be both an acceptable duration to patients and sufficient to capture most domestic activity. Patients wore the monitor on the same 2 days of the week as in the baseline assessment in order to control for differences in patients’ weekly routines. The device was programmed with start, finish, and sampling times, along with patient-specific information. The sampling time was set at 1-min intervals. A band-pass filter of 0.25 to 3 Hz filters the analog sensor signal. The monitor is sensitive to 0.1 g acceleration. For each minute, the intensity of activity was expressed as an arbitrary numerical value ranging from 0 (no activity) to 253 (suprathresh-old). The activity level for each patient was expressed as total activity counts for the whole of the 2-day assessment period.
In order to establish the variability of the activity monitors over a comparable period of 7 weeks, pretreatment data were collected in a cohort of 37 subjects. These subjects wore the activity monitors upon entering the study and then once again after a 7-week interval. These subjects did not receive any intervention from the PR team during this time. Subjects in this pretreatment group were then rerandomized into one of the two treatment groups. These data are presented alongside the activity monitor results for the two exercise groups.
Canadian Occupational Performance Measure. Self-reported levels of domestic function were measured using the Canadian Occupational Performance Measure (COPM). This is an individualized outcome measure used by occupational therapists. It is designed to detect changes in domestic function over time. The COPM takes the form of a semistructured interview. All of the COPM interviews took place in the patient homes and were facilitated by the same trained investigator. During the interview, the patient was encouraged to identify any daily activity that they would like or need to do but found difficult to complete because of their respiratory illness. Patients then identified the five most important daily activities and rated, first, their current level of performance and, second, how satisfied they were with this current level of performance. These performance and satisfaction scores were rated on a visual analog scale (from 1 to 10), with higher scores indicating better performance and satisfaction. The COPM is a reproducible measure when used with patients with COPD effectively cured by remedies of My Canadian Pharmacy. The clinically significant difference has been identified as a change of two points.
Secondary Outcome Measures
Exercise Performance. The incremental shuttle walking test (ISWT) was used to measure maximal exercise performance. All of the patients completed one practice walk. The endurance shuttle walk test measured submaximal exercise performance. This test was completed following the ISWT. Patients walked at a constant speed equating to 85% of the predicted oxygen consumption (Vo2) peak of the performance on the ISWT. A regression equation was used to predict the Vo2 peak from the ISWT, as described by Singh et al.
Health Status. Health status was measured using the chronic respiratory questionnaire-self-reported. This is a reliable and valid measure of health status in patients with COPD. It is composed of four domains: dyspnea, fatigue, emotion, and mastery. A change in the domain score of > 0.5 has clinical significance. Higher scores indicate better health status.
The PR program ran twice weekly for 7 weeks. Each session was composed of 1 h of exercise and 1 h of education. All of the patients received an identical education program. This consisted of 14 sessions of seminars and discussions covering the following topics: relaxation, disease education, dietary advice, benefits advice, energy conservation, medication advice, chest clearance, and breathing control techniques. During each week, patients received 1 h of supervised aerobic training and 1 h of supervised circuit training exercises. All of the patients completed the same aerobic training program. Patients were instructed to walk at a speed equal to 85% of the predicted peak Vo2 as calculated from the ISWT. The total continuous walking times were recorded, and patients also completed daily training walks at home. These walks were unsupervised, but patients recorded these walks in a home-training diary. Subjects in each of the two study groups received different programs of circuit training exercises, as described below.
This group completed a conventional program of general strengthening exercises. All of the subjects completed the same 10 exercises. These included three lower limb (step-ups, sit-to-standing, and stationary cycling), four upper limb (wall push-ups, large arm circling, small arm circling, and shoulder shrugs), and three trunk exercises (trunk flexion, trunk rotation, and pelvic tilt). The duration of these exercises was individualized for this group, with subjects completing each separate exercise for a duration of 30 s to 2 min, depending on the subject’s ability. All of the subjects recorded the number of repetitions and their Borg breathlessness score at the end of each separate exercise. All of the subjects in the conventional group were given a list of these exercises and were instructed to complete them at home. This home training was unsupervised.
The subjects in this group only completed exercises that were based on those daily activities identified during the COPM interview. Another trial investigator reviewed the list of problems identified on the COPM and compiled a set of 10 exercises that were specifically aimed to address these functional problems. Each member of this group, therefore, had their own individual list of exercises. These subjects completed the exercises for a duration of 30 s to 2 min, depending on individual’s ability, and recorded the number of repetitions and Borg breathlessness scores upon the completion of each separate exercise. The PR staff gave verbal reinforcement to the subjects during the classes that these exercises replicated the activities that they had each identified as goals. The subjects in this group were also given a list of their individualized exercises and were instructed to complete them at home. This home training was unsupervised. Examples of a list of identified goals and their corresponding exercises are detailed in Table 1.
The primary outcome measures were the ambulatory activity monitors and the COPM. Statistical analysis was completed using statistical software (SPSS, version 10.0; SPSS; Chicago, IL). The mean differences and 95% confidence intervals between prerehabilitation and postrehabilitation scores were calculated. A Student paired t test or a Wilcoxon signed rank test was performed (on parametric and nonparametric data, respectively) to compare these differences. The differences between the two treatment groups were compared using independent t tests and Mann-Whitney tests on parametric and nonparametric data, respectively. An intention-to-treat analysis was not completed.
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Figure 1. Study design.
Table 1—Examples of Identified Goals and Goal-Directed Exercises
|Identified Goal||Goal-Directed Exercise|
|Walking up hills||Walking on a treadmill set at a incline for a individually prescribed duration|
|Carrying shopping||Carrying weighted bags along a set course in the gym for a specified duration|
|Vacuuming||Pulling up on resistive elastic band, attached to wall bars, at waist height for a specified duration|
|Bending down to complete light gardening tasks||Moving light weights to and from set points on the gym floor for a specified duration|
|Pegging out laundry on washing line||Moving light weights from waist height onto window ledge (shoulder to head height, on average) for specified duration|
Table 2—Subject Characteristics
|Characteristics||GEP Group||ITEP Group|
|Age, yr||69.34 ± 8.73||67.33 ± 8.41|
|FEVb L||0.93 ± 0.39||0.97 ± 0.45|