| | Effects of a long-term exercise program on lower limb mobility, physiological responses, walking performance, and physical activity levels in patients with peripheral arterial diseaseReceived 14 August 2007; accepted 22 October 2007. ObjectiveThe purpose of the study was to examine the effects of a 12-month exercise program on lower limb mobility (temporal-spatial gait parameters and gait kinematics), walking performance, peak physiological responses, and physical activity levels in individuals with symptoms of intermittent claudication due to peripheral arterial disease (PAD-IC). MethodsParticipants (n = 21) with an appropriate history of PAD-IC, ankle-brachial pressure index (ABI) <0.9 in at least one leg and a positive Edinburgh claudication questionnaire response were prospectively recruited. Participants were randomly allocated to either a control PAD-IC group (CPAD-IC) (n = 11) that received standard medical therapy and a treatment PAD-IC group (TPAD-IC) (n = 10), which also took part in a 12-month supervised exercise program. A further group of participants (n = 11) free of PAD (ABI >0.9) and who were non-regular exercisers were recruited from the community to act as age and mass matched controls (CON). Lower limb mobility was determined via two-dimensional video motion analysis. A graded treadmill test was used to assess walking performance and peak physiological responses to exercise. Physical activity levels were measured via a 7-day pedometer recording. Differences between groups were analyzed via repeated measures analysis of variance (ANOVA). ResultsThe 12-month supervised exercise program had no significant effect on lower limb mobility, peak physiological responses, or physical activity levels in TPAD-IC compared with CPAD-IC participants. However, the TPAD-IC participants demonstrated significantly greater walking performance (171% improvement in pain free walking time and 120% improvement in maximal walking time compared with baseline). ConclusionThe results of this study confirm that a 12-month supervised exercise program will result in improved walking performance, but does not have an impact on lower limb mobility, peak physiological responses, or physical activity levels of PAD-IC patients. Patients with symptoms of intermittent claudication due to peripheral artery disease (PAD-IC) have reduced walking performance, peak physiological responses, lower limb mobility (temporal-spatial gait parameters and gait kinematics), physical activity levels, and perceived health related quality of life (QOL) compared with healthy age-matched controls.1, 2, 3, 4, 5 PAD-IC is usually treated conservatively with medications to reduce cardiovascular disease risk-factors; however, patients often continue to have impaired QOL. For severe PAD-IC, surgery is often the most appropriate treatment for QOL outcomes.6, 7 Regardless of the initial treatment, PAD-IC patients are encouraged to increase their physical activity levels, thereby reducing the risk factors associated with the condition.8 PAD-IC patients have been reported to walk significantly further following a 3-month supervised exercise program consisting of intermittent walking.9 Although exercise programs have demonstrated improved walking performance,9, 10, 11 the exact mechanisms for the improvement have not been demonstrated. Increased cardiac output, development of collateral lower limb arteries, improved efficiency of oxygen delivery, adaptation of muscle metabolism, and changes in lower limb mobility6, 12 have been suggested as contributors to improved walking performance; however, there is no consensus as to the major contributing factors. Most PAD-IC studies have employed short-term exercise programs.9, 10, 11, 13 To date, there have been only two studies that investigated the effects of a longer (12 months) term exercise program on walking performance in PAD-IC patients.14 Important factors such as the duration and intensity of the exercise may be central to improved walking performance. Also, there has been no long-term examination of the lower limb mobility of individuals with PAD-IC in order to determine if the reduced lower limb mobility in this population can be modified to more closely resemble healthy age-matched controls. Gardner et al3 speculated that the reduced temporal-spatial gait parameters could be modified to resemble that of age-matched controls through the use of an exercise program. Therefore, the aim of this study was to examine the effects of a 12-month supervised exercise program on the lower limb mobility of individuals with PAD-IC during pain free walking. A further aim was to examine the extent to which lower limb mobility contributes to long-term exercise induced changes in walking performance, peak physiological responses, and physical activity levels in PAD-IC patients. It was hypothesized that a long-term supervised exercise program would result in improved lower limb mobility during pain free walking, which in turn would be reflected in improved functional capacity; that is, improved walking performance, increased peak physiological responses to acute exercise, and augmented levels of physical activity. Methods  Participants Between January 2003 and 2006, patients referred to the vascular department at the Townsville Hospital with symptoms of intermittent claudication were considered for inclusion in the study. Entry criteria included an appropriate history of intermittent claudication, imaging confirmation of PAD on lower limb duplex or computed tomographic angiograph (CTA), and ability and willingness to attend regular supervised exercise. Approximately 50% of patients attending our vascular department live >200 km away. Thus, the main reason for excluding patients was the inability to attend the program (n = 48). Other reasons for exclusion included selection for surgical or endovascular intervention (n = 30), patient preference (n = 20), and requirement for mobility aids, obvious gait abnormalities (eg, circumduction) or medical conditions that influenced gait (eg, orthopedic conditions and neurological impairment) (n = 20). All patients were assessed by a consultant vascular physician. PAD-IC was confirmed by absence of peripheral pulses, lower limb artery stenosis, or occlusion on duplex or CTA, ankle-brachial pressure index (ABI) <0.9 and positive Edinburgh Claudication Questionnaire response.15 Five participants withdrew from the study following baseline testing citing health, changed address, and personal motivation reasons. Participants were randomly allocated using a double blind protocol to either a control (CPAD-IC, n = 11) or treatment group (TPAD-IC, n = 10). All participants were reviewed by a vascular surgeon and consultant physician to optimize their atherosclerosis risk factor management, which included recommendations to modify smoking habits, diet, medication, and to undertake regular physical activity. Patients randomized to the TPAD-IC experimental condition also undertook a 12-month supervised exercise program. A third group of participants (n = 11) free of PAD based on normal ABI and peripheral pulses and who were non-regular exercisers were recruited from the general community via e-mail bulletin boards, local newspaper, and television coverage to act as age and mass matched controls (CON). Comorbidity, medication, and smoking history were determined at consultation by a vascular physician. All participants volunteered and gave written informed consent to participate in this study as approved by the institutional ethics committee. The descriptive characteristics of the participants are outlined in Table I. Procedure Participants arrived at the laboratory in the early morning whilst in a fasting state (12 hours) and underwent, body composition, resting ABI, gait, and exercise performance testing at 0 and 12 months. Anthropometry Participant height was determined by a wall mounted stadiometer (Seca, model 220, Seca Scales, Hamburg, Germany). Body mass and composition (% body fat) were determined via bioelectrical impedance scales (TANITA TBF 521, TANITA Corporation, Arlington Heights, Ill). Body mass index (BMI) was calculated as (mass in kg/[(height in m)2]). Ankle-brachial index (ABI) Blood pressure measurements were taken by a qualified sonographer using a handheld bidirectional Doppler instrument (MD6, Hokanson, Bellevue, Wash) with a 5-MHz transducer and standard blood pressure cuffs after the participant had rested in the supine position for 10 minutes. ABI was calculated as the highest systolic blood pressure in the posterior tibial artery or dorsalis pedis artery divided by the highest systolic blood pressure in the left or right brachial artery.16 Lower limb mobility Major joint segments were identified using reflective markers placed on five landmarks on the ipsilateral (right side) of the participant’s body. The landmarks were determined via palpation, and the markers were positioned at the shoulder (acromion), hip (greater trochanter of femur), knee (lateral epicondyle of femur), ankle (lateral malleolus of fibula), and head of the fifth metatarsal. Participants were instructed to walk normally without shoes along a 10 m walkway that was marked at 1 cm intervals whilst the participant was in a pain free state. Digital imagery was obtained via a high-speed digital video camera (Canon MV550i, Canon Australia, North Ryde, Australia) set at a frame rate of 50 Hz and placed 3 m perpendicular to the line of motion providing an uninterrupted video field. Five complete trials were achieved. A walking trial was deemed to be complete and suitable for analysis if all anatomical markers were visible at the first and last ipsilateral heel strike. Three walking trials (one stride per trial) were then randomly selected for kinematic analysis.17 During the recording of video footage, digital images were captured via a video capture card (Adaptec FireConnect for Notebooks, Adaptec Inc, Milpitas, Calif) and appropriate lower limb joints were identified and named with digitizing software (SiliconCoach Ltd, Dunedin, New Zealand) operating on a laptop computer (Toshiba PIV, Toshiba Australia, North Ryde, Australia). Two markers were placed 1 m apart on the floor in the direction of travel in order to calibrate the digitizing software. The first author performed all digitizing of the digital video images in order to prevent inter-individual variability in anatomical marker identification. The intraclass correlation coefficient (ICC) values for the digitized X and Y coordinate data ranged from 0.9 to 0.95. The ICC data for within-participant gait kinematic measures ranged from 0.8 to 0.85. Data points were used to calculate gait kinematic parameters including peak displacements, velocities, and acceleration for the ipsilateral lower limb joints. The figure outlines the joint angle conventions used to determine the kinematic variables. Temporal-spatial gait parameters determined included stride length, stride cadence, contact time, flight time, initial double support time, ipsilateral leg support time, final double support time, contralateral leg support time, total time, and speed. Stride length was calculated as the distance from successive initial ground contacts of the ipsilateral foot. Treadmill testing Following lower limb mobility assessment, participants undertook a graded exercise test on a treadmill (Trackmaster TMX55, Full Vision, Newton, Kan) for determination of walking performance and physiological responses to acute exercise. The peak physiological responses included oxygen uptake (VO2peak), respiratory exchange ratio (RERpeak), ventilation (VEpeak), and heart rate (HRpeak). The physiological responses were determined via indirect calorimetry using a metabolic cart (Power LAB/8M Metabolic System, AD Instruments Pty Ltd, Castle Hill, Australia). The metabolic gas analysis system was calibrated with a 3 L syringe, temperature (°C), barometric pressure (mm Hg), airflow (L), body mass (kg), room air (20.93% and 0.03% for O2 and CO2, respectively), and alpha gas composition (∼10% O2, ∼7% CO2) (BOC, Melbourne, Australia). Before the test began, the participant was fitted with a headpiece that held a rubber mouthpiece connected to a T-shaped two-way non-rebreathing value (Hans Rudolph, Inc, Kansas City, Mo), which in turn was connected to the mixing chamber of the metabolic gas analysis system by 35 mm diameter smooth bore hosing. Electrocardiogram electrodes (silver/silver chloride electrodes, 3M, Pymble, Australia) were positioned at the manubrium, seventh cervical vertebrae and fifth intercostal-axiliary line (lead II) for the recording of an electrocardiogram. All physiological responses were recorded continuously using Chart (v5.1, AD Instruments Pty Ltd, Castle Hill, Australia) sampling at 1000 Hz and were analyzed post test as 15-second averages. The graded treadmill walking protocol consisted of a constant speed of 3.2 km·h−1 and an incline of 0% for the first 2 minutes, which was then increased by 2% every 2 minutes.18 Participant perception of exercise exertion was determined every 60 seconds via Borg’s19 Rating of Perceived Exertion (RPE) instrument while participant perception of claudication pain was determined via a 5-point (0 = no pain, 1 = onset of pain, 2 = moderate pain, 3 = intense pain, 4 = maximal pain) claudication pain scale (CPS).20 Walking performance was assessed as pain free walking time (PFWT) and maximal walk time (MWT) either by perceived maximal pain, volitional exhaustion, or until 25 minutes of walking was achieved. Participants were permitted to hold the treadmill handrail if they required support whilst walking and a number of common motivational phrases (eg, you can make it, keep walking) were used to encourage participants. Motivational phrase usage was standardized by noting the frequency and type of phrase used in pilot and preliminary testing. Exercise test termination criteria included voluntary exhaustion and significant abnormal ECG rhythm. Physical activity level Following laboratory testing, participant physical activity levels were determined from 7-day pedometer (YAMAX DigiWalker SW-700, YAMAX Corporation, Tokyo, Japan) recordings. Physical activity level was determined as number of steps, distance walked, and calories expended during walking. The TPAD-IC participants did not wear a pedometer during supervised exercise sessions in order to allow between group comparisons of physical activity levels outside the laboratory. Supervised exercise program The exercise program initially consisted of supervised treadmill walking 3 d·wk−1 for 25 minutes at 3.2 km·hr−1. Participants were required to walk until the pain level was perceived as being 3 or 4 on the CPS. Exercise intensity (via treadmill grade and walking speed) and duration (25 up to 40 minutes) was progressively increased once the participant could walk without stopping for 25 minutes below the pain CPS levels of 3 or 4. This exercise progression strategy was continued over the 12-month period. Statistical analyses Statistical analysis was performed using the SPSS (SPSS Inc, release 14.0, Chicago, Ill) software program. Descriptive statistics were expressed as mean (±SD). Box-plot analyses were performed to identify extreme and outlier data. Data were analyzed using repeated measures analysis of variance (ANOVA) with one between-subjects factor (CON versus CPAD-IC versus TPAD-IC) and one within subject factor (time - 0 versus 12 months). Post hoc analysis was performed using the Tukey HSD test. Medication and comorbidities data were analyzed using the nonparametric Friedman test and post hoc comparison using Nemenyi’s test. An alpha level of .05 was adopted for this study.21 Results  Participants The groups were similar in age, height, mass, % body fat, and BMI at baseline and no significant changes occurred over the 12-month study period (Table I). As expected, ABI values were higher in the CON group (P < .001) than both PAD-IC groups (Table I). ABI measures indicated an equal number of right and left side index (worst) legs. Both PAD-IC groups included a higher proportion of former smokers (P < .05) compared with the CON group. The CPAD-IC group contained a higher proportion of patients who had been prescribed beta-blocker medication (P < .05) compared with the TPAD-IC and CON groups (Table I). Lower limb mobility There were significant between group differences for stride length, cadence, stride time, contact time, speed, and reduced double support time (1 and 2) for the CON group compared with the CPAD-IC and TPAD-IC groups (Table II). There were no significant differences between the CPAD-IC and TPAD-IC groups at 0 and 12 months for all temporal-spatial gait parameters and gait kinematics. The 12-month supervised exercise program had no significant impact on the temporal-spatial gait parameters or gait kinematics of the TPAD-IC participants (Table II). Treadmill testing The CON group demonstrated significantly greater MWT compared with the TPAD-IC and CPAD-IC groups. PFWT and MWT were significantly greater for the TPAD-IC group following the 12-month supervised exercise program compared with the CPAD-IC group (Table III). The TPAD-IC group also demonstrated significantly improved PFWT and MWT at 12 months compared with baseline. Significantly higher VO2peak and HRpeak values were determined for CON group compared with the PAD-IC groups. The 12-month supervised exercise program had no significant effect on any of the physiological responses (HRpeak, VO2peak, VEpeak, and RERpeak) for the TPAD-IC group compared with the CPAD-IC and CON groups (Table III). Physical activity level The CON group demonstrated significantly greater physical activity levels (number of steps, walk distance, and calorie expenditure) compared with the PAD-IC groups over the 7-day pedometer recording period (Table IV). The 12-month supervised exercise program had no significant effect on the physical activity levels of the TPAD-IC participants compared with the CPAD-IC and CON participants outside the supervised training sessions. However, at the end of the 12-month exercise program, the TPAD-IC participants walked an additional 3.9 to 6.9 km · wk−1. Discussion  The purpose of this study was to investigate the effects of a 12-month supervised exercise program on individuals with PAD-IC. To our knowledge, this study was the first to examine the lower limb mobility characteristics (temporal-spatial gait parameters and gait kinematics) of individuals with PAD-IC over a 12-month period. Because lower limb mobility characteristics have been shown to predict functional decline22, 23, 24, 25 and fall risk,26, 27, 28, 29 it is very important to understand how PAD-IC affects patient lower limb mobility. The results of this study demonstrated that a 12-month supervised exercise program did not alter the lower limb mobility characteristics of PAD-IC patients. Gardner et al3 speculated that exercise programs could be used to improve lower limb mobility in individuals with PAD-IC to the extent that their mobility characteristics more closely resemble that of healthy age-matched controls. However, this view was not supported by our data. Studies that have reported increased lower limb mobility in healthy aged populations were exercise intensity and dosage dependant.30 Thus, the exercise intensity and dosage adopted for the current study may not have been sufficient to elicit improved lower limb mobility in the PAD-IC patients. However, a more frequent or intense exercise program is unlikely to be feasible in practice. As in other studies, we were only able to recruit a small proportion of the population of patients presenting with intermittent claudication and a more intense exercise program would potentially have made recruitment even more problematic. Although lower limb mobility was not altered in TPAD-IC participants, the 12-month supervised exercise program produced significantly higher treadmill walking performance compared with baseline and the CPAD-IC participants at 12 months. This result is similar to previous studies on the effects of exercise programs on walking performance in this population.9, 31, 32 However, there was no improvement in the physical activity levels (outside the supervised exercise sessions) of patients undergoing supervised exercise as assessed by 7-day pedometer measurements, although there was a trend in this direction (Table IV). We also found no changes in physiological responses (HRpeak, VO2peak, VEpeak, and RERpeak) for either of the intervention groups. The lack of improvement in physiological responses, especially VO2peak, may have been due to the intermittent nature of the exercise program undertaken by the TPAD-IC patients. These participants ceased walking when they reached a pain intensity of 3 to 4 on the CPS. This exercise regime would have had a limited impact on central adaptation processes underlying peak oxygen consumption. The results of this study show that lower limb mobility and physiological responses may not be the mechanism underlying improved walking performance in PAD-IC patients following a supervised exercise program. The mechanism may be peripheral in nature for example, improved blood flow, mitochondrial oxidative capacity, skeletal muscle diffusive capacity, capillary growth, and/or improved oxygen perfusion in the area of the arterial obstruction.6, 33, 34, 35 In our opinion, another plausible mechanism could be the impact of adaptation to claudication pain with PAD-IC patients becoming more tolerant of claudication pain due to the progressive nature of exercise programs. Also, lower limb mobility characteristics were only measured during pain free walking. Lower limb mobility may alter during the gradual onset of claudication pain and/or at maximal claudication pain levels. Conclusion  The results of this study demonstrated that a 12-month supervised exercise program results in improved walking performance in PAD-IC patients but does not alter central physiological characteristics during exercise, reported physical activity levels, or lower limb mobility during pain free walking. Power values for the temporal-spatial gait parameters ranged from low to moderate for this sample size. Future research should use larger sample sizes to increase the power for these variables. The improved walking performance may be due to peripheral physiological mechanisms and the effects of intensity and dosage of exercise. Author contributions  Conception and design: RC, WS, AL, FQ, JG Analysis and interpretation: RC, WS, AL Data collection: RC, AL Writing the article: RC, WS Critical revision of the article: WS, AL, KS, FQ, JG Final approval of the article: RC, WS, AL, KS, FQ, JG Statistical analysis: RC Obtained funding: WS, AL, JG Overall responsibility: WS, AL, JG References  1. 1Breek JC, Hamming JF, De Vries J, Aquarius AE, van Berge Henegouwen DP. Quality of life in patients with intermittent claudication using the World Health Organization (WHO) questionnaire. Eur J Vasc Endovasc Surg. 2001;21:118–122. Abstract |
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Competition of interest: none. PII: S0741-5214(07)01740-5 doi:10.1016/j.jvs.2007.10.038 © 2008 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. | |
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