Effect of a Graduated Walking Program on the Severity of Obstructive Sleep Apnea Syndrome. A Randomized Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.1.1. Population
2.1.2. Subject Selection
2.1.3. Sample Size
2.1.4. Intervention
2.1.5. Bias Control
- Randomization. A random number table was prepared by a statistician who did not participate in the study, using the sampling module of the software Epidat 4.1 (Department of Sanidade, Xunta de Galicia, Galicia, Spain). The ratio of subjects assigned to each group was 1:1.
- The measures for keeping the research team blinded were as follows. The random numbers were kept in sealed envelopes by the Sleep Unit staff who did not participate in the assessment of the outcomes. The subjects were always monitored by the same researcher and no information was given to them about the therapeutic arm they were assigned to. After randomization, the subjects assigned to the interventional group were referred to physiotherapist, while the subjects of the control group continued with their usual care. Information on the therapeutic arm assigned to the patient, the clinical trial nature, or the research hypothesis was avoided. Furthermore, although the physiotherapist knew only the patients in the experimental group, he did not intervene in any way in measuring the effect of the intervention. Finally, the primary outcome (change in the AHI) is an objective determination (sleep test) that cannot be modified by the information given to the patient. For the follow-up, the telephone calls were made by a blinded researcher (she did not know who was assigned to the control or intervention group). They were only performed to reinforce the patient’s continuity in the study and to resolve any doubts.
- Control for healthy habits. All individuals were advised to maintain a stable sleep habit for at least 7 h at night, to refrain from drinking alcohol and taking muscle relaxants during the evening, and to maintain the dietary pattern recommended by the American Heart Association [18]. These recommendations and an explanatory leaflet were provided.
2.2. Measures
2.2.1. Clinical Characteristics
2.2.2. Cardiorespiratory Polygraphy
2.2.3. Physical Activity
2.3. Outcomes
2.4. Data Analysis
3. Results
4. Discussion
Limitations
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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Anthropometric Data | Intervention Group (n = 34) | Control Group (n = 34) | p-Value |
---|---|---|---|
Age (years) | 52 ± 6.6 | 50 ± 9.5 | 0.335 |
Men, n (%) | 20 (59) | 23 (67) | 0.615 |
BMI (kg/m2) | 32 ± 5.2 | 32 ± 4.3 | 0.527 |
Neck circumference (cm) | 41 ± 3.5 | 40 ± 3.8 | 0.620 |
Waist-to-hip ratio | 0.94 ± 0.529 | 0.94 ± 0.1 | 0.992 |
Physical Activity | |||
YPAS, Score | 35 ± 10.6 | 34 ± 10.7 | 0.659 |
Questionnaires | |||
ESS, Score | 9 ± 4.5 | 10 ± 4.3 | 0.370 |
FOSQ, Total Score | 79 ± 19.3 | 77 ± 17.1 | 0.577 |
General Productivity Score | 3.2 ± 0.82 | 3.1 ± 0.68 | 0.575 |
Activity Level Score | 3.0 ± 0.84 | 3.0 ± 0.68 | 0.863 |
Vigilance Score | 2.9 ± 1.01 | 3.0 ± 0.83 | 0.639 |
Social Outcomes Score | 3.4 ± 1.04 | 3.4 ± 1.01 | 0.972 |
Intimacy and Sexual Relationships Score | 3.2 ± 2.82 | 2.8 ± 1.27 | 0.166 |
Sleep-Disordered Breathing | |||
AHI | 29 ± 19.7 | 27 ± 10.4 | 0.604 |
SpO2 mean (%) | 94 ± 1.6 | 94 ± 1.7 | 0.677 |
T90 (%) | 5.7 ± 11.64 | 3.6 ± 10.32 | 0.441 |
Oxygen desaturation index | 33 ± 21.1 | 25 ± 10.7 | 0.032 |
Biochemical Parameters | |||
Urea (mg/dL) | 35.7 ± 11.47 | 31.8 ± 6.47 | 0.093 |
Creatinine (mg/dL) | 0.85 ± 0.286 | 0.80 ± 0.102 | 0.385 |
ALT (U/L) | 28 ± 10.5 | 25 ± 10.5 | 0.252 |
AST (U/L) | 23 ± 6.4 | 21 ± 5.0 | 0.272 |
Blood glucose (mg/dL) | 104 ± 16.5 | 94 ± 14.8 | 0.014 |
Total Cholesterol, (mg/dL) | 206 ± 31.6 | 204 ± 46.1 | 0.881 |
HDL-col, (mg/dL) | 46 ± 11.4 | 48 ± 14.4 | 0.441 |
LDL-col, (mg/dL) | 132 ± 28.4 | 137 ± 23.4 | 0.452 |
TGL, (mg/dL) | 138 ± 69.1 | 132 ± 66.9 | 0.728 |
Variables | Intervention Group (n = 29) | Control Group (n = 29) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | After 6 Months | Mean Difference | 95% IC | p-Value | Baseline | After 6 Months | Mean Difference | 95% IC | p-Value | |
Anthropometric Data | ||||||||||
BMI (kg/m2) | 32 ± 4.1 | 31 ± 4.1 | 0.759 | 0.087–1.431 | 0.028 | 32 ± 4.3 | 31 ± 4.5 | 0.653 | 0.195–1.111 | 0.007 |
Neck circumference (cm) | 40.8 ± 3.61 | 39.8 ± 2.95 | 0.982 | 0.420–1.544 | 0.001 | 40.8 ± 3. | 39.8 ± 2.92 | 0.845 | 0.373–1.316 | 0.001 |
Waist-to-hip ratio | 0.94 ± 0.06 | 0.94 ± 0.052 | 0.007 | −0.022–0.007 | 0.325 | 0.93 ± 0.08 | 0.93 ± 0.08 | 0.004 | −0.009–0.016 | 0.543 |
Physical Activity | ||||||||||
Steps/day | - | 4380 ± 3018 | NA | - | 3778 ± 2273 | NA | ||||
Questionnaires | ||||||||||
ESS, Score | 9.9 ± 4.42 | 7.7 ± 4.47 | 2.172 | 0.898–3.446 | 0.013 | 9.8 ± 4.56 | 9.2 ± 3.89 | 0.724 | −0.529–1.977 | 0.292 |
FOSQ, Total Score | 32 ± 4.1 | 31 ± 4.1 | 5.720 | −10.407–1.034 | 0.028 | 32 ± 4.3 | 31 ± 4.5 | 0.086 | −7.715–7.887 | 0.007 |
General Productivity Score | 3.2 ± 0.70 | 3.4 ± 0.70 | −0.196 | −457–0.064 | 0.133 | 3.2 ± 0.63 | 3.1 ± 0.72 | 0.069 | −0.151–0.289 | 0.526 |
Activity Level Score | 3.0 ± 0.88 | 3.3 ± 0.54 | −0.357 | −0.639–(−0.075) | 0.015 | 3.0 ± 0.71 | 3.2 ± 0.61 | −0.189 | −0.393–0.014 | 0.067 |
Vigilance Score | 2.9 ± 1.05 | 3.4 ± 0.74 | −0.500 | 0.854–(−0.146) | 0.007 | 3.0 ± 0.89 | 3.2 ± 0.65 | −0.234 | −0.529−0.059 | 0.114 |
Social Outcomes Score | 3.3 ± 1.12 | 3.5 ± 0.88 | −0.214 | −0.600–0.171 | 0.264 | 3.4 ± 1.08 | 3.4 ± 0.73 | −0.034 | −0.434–0.365 | 0.861 |
Intimacy and Sexual Relationships Score | 3.2 ± 1.17 | 3.2 ± 1.25 | 0.071 | −0.163–0.306 | 0.537 | 2.8 ± 1.28 | 3.1 ± 1.13 | −0.241 | −0.668–0.186 | 0.257 |
Sleep-Disordered Breathing | ||||||||||
AHI | 29 ± 20.8 | 23 ± 13.1 | 6.062 | −0.242–10.366 | 0.126 | 27 ± 9.9 | 25 ± 16.29 | 1.152 | −4.915–7.218 | 0.778 |
SpO2 mean (%) | 93 ± 1.7 | 93 ± 2.5 | 0.176 | −0.565–0.916 | 0.630 | 94 ± 1.8 | 94 ± 1.9 | −0.243 | −0.974–0.487 | 0.501 |
T90 (%) | 6 ± 6.4 | 6 ± 5.1 | 0.540 | −3.829–4.909 | 0.802 | 4 ± 4.14 | 4 ± 4.2 | 0.033 | −4.952–5.017 | 0.989 |
Oxygen desaturation index | 33 ± 22.4 | 27 ± 18.9 | 6.091 | −0.464–12.647 | 0.067 | 25 ± 11.0 | 25 ± 15.4 | 0.368 | −5.587–6.323 | 0.900 |
Biochemical Parameters | ||||||||||
Urea (mg/dL) | 37 ± 12.2 | 38 ± 12.7 | −1.500 | −4.491–1.491 | 0.313 | 32 ± 6.4 | 33 ± 8.6 | −1.552 | −4.783–1.680 | 0.334 |
Creatinine (mg/dL) | 0.84 ± 0.31 | 0.86 ± 0.38 | −0.017 | −0.094–0.061 | 0.661 | 0.79 ± 0.09 | 0.79 ± 0.135 | 0.001 | −0.030–0.031 | 0.982 |
ALT (U/L) | 28 ± 11.1 | 25 ± 8.1 | 2.798 | −1.173–6.745 | 0.160 | 25 ± 11.1 | 24 ± 10.6 | 0.966 | −2.454–4.385 | 0.568 |
AST (U/L) | 23 ± 6.5 | 21 ± 5.2 | 1.786 | −1.084–4.655 | 0.213 | 20 ± 4.7 | 21 ± 7.5 | −0.862 | −3.771–2.047 | 0.549 |
Blood glucose (mg/dL) | 103 ± 17.7 | 100 ± 33.6 | 3.250 | −5.053–11.553 | 0.429 | 95 ± 15.8 | 95 ± 13.6 | 0.103 | −3.958–4.165 | 0.959 |
Total cholesterol (mg/dL) | 206 ± 32.1 | 194 ± 37.5 | 12.786 | −0.246–25.817 | 0.054 | 203 ± 47.7 | 206 ± 36,1 | −2.926 | −23.206–17.353 | 0.770 |
HDL-col, (mg/dL) | 46 ± 9.4 | 47 ± 9.5 | −0.714 | −3.912–2.483 | 0.650 | 48 ± 14.9 | 50 ± 12.3 | −1.448 | −5.245–2.348 | 0.441 |
LDL-col, (mg/dL) | 132 ± 28.7 | 121 ± 33.6 | 10.643 | −0.090–21.376 | 0.052 | 136 ± 22.7 | 129 ± 31.7 | 7.310 | −2.183–16.804 | 0.126 |
TGL (mg/dL) | 138 ± 74.2 | 134 ± 81 | 4.393 | −24.381–33.166 | 0.756 | 132 ± 71.7 | 131 ± 57.1 | 1.034 | −17.462–19.531 | 0.910 |
Variables | Moderate OSAS Group (n = 41) | Severe OSAS Group (n = 17) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | After 6 Months | Mean Difference | 95% IC | p-Value | Baseline | After 6 Months | Mean Difference | 95% IC | p-Value | |
Anthropometric Data | ||||||||||
BMI (kg/m2) | 32 ± 3.8 | 31 ± 4.1 | 0.530 | 0.055–1.005 | 0.030 | 32 ± 5.0 | 30 ± 4.7 | 1.117 | 0.393–1.841 | 0.005 |
Neck circumference (cm) | 40 ± 3.2 | 39 ± 3.1 | 0.850 | 0.412–1.289 | 0.001 | 41 ± 4.6 | 40 ± 3.7 | 1.058 | 0.404–1.713 | 0.003 |
Waist-to-hip ratio | 0.93 ± 0.07 | 093 ± 0.067 | −0.002 | −0.011–0.007 | 0.632 | 0.94 ± 0.064 | 0.94 ± 0.062 | 0.000 | −0.024–0.024 | 1.000 |
Physical Activity | ||||||||||
Steps/day | - | 4261 ± 2026.3 | NA | - | 3633 ± 2462.8 | NA | ||||
Questionnaires | ||||||||||
ESS, Score | 9.7 ± 4.43 | 8.5 ± 3.95 | 1.561 | 0.601–2.521 | 0.012 | 8.7 ± 4.61 | 8.3 ± 4.95 | 1.176 | −0.961–3.314 | 0.587 |
FOSQ, Total Score | 76 ±18.0 | 81 ± 15.0 | −4.434 | −8.753–(−0.114) | 0.044 | 81 ± 20.4 | 80 ± 23.4 | 1.159 | −10.841–13.158 | 0.840 |
Sleep-Disordered Breathing | ||||||||||
AHI | 20 ± 4.76 | 23 ± 15.7 | 1.683 | −5.660–2.294 | 0.228 | 45 ± 20.6 | 30 ± 26.3 | 14.659 | 7.356–21.961 | 0.002 |
SpO2 mean (%) | 94 ± 1.6 | 94 ± 2.2 | 0.148 | −0.449–0.745 | 0.620 | 93 ± 1.9 | 93 ± 2.3 | −0.471 | −1.501–0.560 | 0.347 |
T90 (%) | 5 ± 6.2 | 4 ± 4.3 | 0.285 | −4.092–4.663 | 0.896 | 6 ± 5.9 | 6 ± 4.9 | 0.288 | −3.374–3.950 | 0.870 |
Oxygen desaturation index | 24 ± 9.7 | 23 ± 14.7 | 0.842 | −4.900–5.873 | 0.737 | 43 ± 25.1 | 34 ± 20.2 | 8.988 | 0.182–17.794 | 0.046 |
Biochemical Parameters | ||||||||||
Urea (mg/dL) | 35 ± 30.7 | 36 ± 12.0 | −1.900 | −4.24–0.824 | 0.166 | 33 ± 7.9 | 34 ± 8.2 | −0.647 | −4.237–2.943 | 0.707 |
Creatinine (mg/dL) | 0.81 ± 0.27 | 0.80 ± 0.293 | 0.007 | −0.025–0.040 | 0.645 | 0.84 ± 0.866 | 0.88 ± 0.258 | −0.044 | −0.162–0.073 | 0.432 |
ALT (U/L) | 26 ± 10.5 | 25 ± 10.0 | 0.500 | −2.554–3.554 | 0.742 | 27 ± 12.5 | 22 ± 7.6 | 5.059 | 0.387–9.731 | 0.036 |
AST (U/L) | 22 ± 6.2 | 22 ± 6.9 | 0.000 | −2.673–2.673 | 1.000 | 21 ± 4.7 | 20 ± 5.1 | 1.471 | −1.305–4.246 | 0.278 |
Blood glucose (mg/dL) | 100 ± 18.5 | 98.4 ± 29.1 | 1.875 | −4.398–8.148 | 0.549 | 96 ± 13.8 | 95 ± 14.0 | 1.117 | −2.,287–4.523 | 0.497 |
Total Cholesterol (mg/dL) | 201 ± 42.4 | 200 ± 40.8 | 1.104 | −14.763–16.970 | 0.889 | 214 ± 33.4 | 201 ± 26.7 | 13.471 | −2.678–29.620 | 0.096 |
HDL-col, (mg/dL) | 49 ± 14.3 | 48 ± 11.4 | 0.250 | −2.924–3.424 | 0.874 | 45 ± 7.8 | 49 ± 10.3 | −4.235 | −7.253–(−1.218) | 0.009 |
LDL-col, (mg/dL) | 131 ± 24.2 | 124 ± 36.2 | 6.950 | −1.596–15.496 | 0.108 | 141 ± 28,6 | 127 ± 22.6 | 13.647 | 0.856–26.438 | 0.038 |
TGL (mg/dL) | 134 ± 67 | 139 ± 75.7 | −5.650 | −24.758–13.458 | 0.553 | 37 ± 84.4 | 115 ± 48.7 | 22.294 | −10.853–55.441 | 0.173 |
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Jurado-García, A.; Molina-Recio, G.; Feu-Collado, N.; Palomares-Muriana, A.; Gómez-González, A.M.; Márquez-Pérez, F.L.; Jurado-Gamez, B. Effect of a Graduated Walking Program on the Severity of Obstructive Sleep Apnea Syndrome. A Randomized Clinical Trial. Int. J. Environ. Res. Public Health 2020, 17, 6334. https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17176334
Jurado-García A, Molina-Recio G, Feu-Collado N, Palomares-Muriana A, Gómez-González AM, Márquez-Pérez FL, Jurado-Gamez B. Effect of a Graduated Walking Program on the Severity of Obstructive Sleep Apnea Syndrome. A Randomized Clinical Trial. International Journal of Environmental Research and Public Health. 2020; 17(17):6334. https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17176334
Chicago/Turabian StyleJurado-García, Antonio, Guillermo Molina-Recio, Nuria Feu-Collado, Ana Palomares-Muriana, Adela María Gómez-González, Francisca Lourdes Márquez-Pérez, and Bernabé Jurado-Gamez. 2020. "Effect of a Graduated Walking Program on the Severity of Obstructive Sleep Apnea Syndrome. A Randomized Clinical Trial" International Journal of Environmental Research and Public Health 17, no. 17: 6334. https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17176334