A total of 94 patients with Parkinson's disease were initially screened for the study. Of these, 19 patients did not meet the eligibility criteria, and an additional 15 patients declined to participate, resulting in an enrollment rate of 63.8% (Fig. 2). The 60 participants who were randomized were evenly divided into a control group and an experimental group, with 30 patients in each group. During the course of the experiment, 5 patients from the experimental group withdrew from the study, while 4 patients from the control group refused to participate in the follow-up. Ultimately, 51 participants (85%) completed the intervention, with 25 in the experimental group and 26 in the control group. This resulted in an overall dropout rate of 15% (9 out of 60). The compliance rates for home practice during the intervention period were 83.3% (25 out of 30) for the Liuzijue group and 86.7% (26 out of 30) for the control group. These compliance rates indicate the level of adherence to the prescribed home practice regimen during the study.
Baseline Characteristics of the Participants
Table 1 presents the baseline demographic and clinical characteristics of the participants included in the study. There were no statistically significant differences observed between the intervention and control groups. The mean (SD) age of the participants was 57.92 (9.14) years, with an age range of 49 to 82 years. Of the 51 participants, 27 were female, accounting for 52.94% of the total. The mean (SD) BMI (body mass index) of the participants was 20.74 (1.96). The mean (SD) duration of the disease among the participants was 6.09 (3.56) years, with a range of 1 to 12 years.
Tabel 1 Baseline comparision of Demographics between the two groups(n = 51)
Characteristic
|
ALL
(n=51)
|
Experimental group (n=25)
|
Control group (n=26)
|
P value
|
age, mean(SD),y
|
57.92(9.14)
|
58.80(8.61)
|
58.15(7.09)
|
.730a
|
Sex (male/female), n
|
24/27
|
12/13
|
12/14
|
.432b
|
BMI(kg/m2),mean(SD)
|
20.74 (1.96)
|
20.42(2.16)
|
21.18(1.48)
|
.641
|
Disease duration,
Mean(SD),y
|
6.09 (3.56)
|
6.05(3.07)
|
6.15(4.47)
|
.270
|
Hoehn-Yahr stage,
median (IQR)
|
2(1.5,2.5)
|
2(1.5,2.5)
|
2(2,2.5)
|
.059c
|
LEDD,mean(SD),mg
|
421.46(198.52)
|
393.35(253.43)
|
476.25(218.97)
|
.165
|
MMSE,mean(SD)
|
28.35(1.46)
|
27.05(1.85)
|
28.75(1.32)
|
.188
|
FVC,mean(SD),L
|
2.94(0.54)
|
2.98(0.75)
|
2.91(0.89)
|
.829
|
FEV1,mean(SD),L
|
2.22(0.42)
|
2.18(0.54)
|
2.24(0.31)
|
.935
|
PEF,mean(SD),L/s
|
5.16(1.14)
|
5.13(1.27)
|
5.19(1.34)
|
.898
|
MIP,mean(SD),cmH2O
|
55.08(19.76)
|
55.15(23.15)
|
54.12(20.05)
|
.903
|
MEP,mean(SD),cmH2O
|
94.15(43.41)
|
95.75(32.19)
|
93.55(38.61)
|
.736
|
MDS-UPDRS-Ⅲ
,mean(SD)
|
20.89(13.21)
|
20.65(12.98)
|
22.65(11.91)
|
.457
|
PDQ-39,mean(SD)
|
23.76(16.23)
|
24.15(13.75)
|
23.34(14.18)
|
.457
|
HAMD,mean(SD)
|
7.59(7.64)
|
7.54(8.32)
|
7.67(8.03)
|
.763
|
HAMA,mean(SD)
|
7.42(6.11)
|
7.16(7.34)
|
7.62(5.86)
|
.395
|
Abbreviations:BMI,Body Mass Index;LEDD,levodopa equivalent daily dose;MMSE,Minimum Mental State Examination;FVC,forced vital capacity ;FEV1,forced expiratory volume in 1s;PEF,peak expiratory flow;MIP, maximal inspiratory pressure ;MEP,maximal expiratory pressure; MDS-UPDRS III, Movement Disorders Society United Parkinson’s Disease Rating Scale, Part III; PDQ-39, 39-item Parkinson’s Disease Questionnaire;HAMD,Hamilton Depression Scale;
HAMA,Hamilton Anxiety Scale .
a for continuous data, an independent t test was used.
b for categorical data, a χ2 test was used.
c for ordinal data , a rank sum test was used.
Primary outcome
Table 2 presents the comparisons of within-group outcomes, while Table 3 illustrates the changes in the main outcomes between the two groups after treatment. In this study, FVC, FEV1, PEF, MIP, and MEP were utilized to assess respiratory function. After the treatment period, the experimental group exhibited significant improvements in FVC, FEV1, PEF, and MEP (FVC: 0.13 [95% CI, -0.24 to -0.01]; P = 0.029; FEV1: -0.11 [95% CI, -0.18 to -0.02]; P = 0.015; PEF: -0.14 [95% CI, -0.31 to -0.03]; P = 0.049; MEP: -0.13 [95% CI, -1.67 to -0.04]; P = 0.045). Moreover, compared to those in the control group, these improvements were statistically significant (FVC: 0.46 [95% CI, 0.02 to 0.91]; P = 0.003; FEV1: 0.33 [95% CI, 0.01 to 0.76]; P = 0.021; MEP: -5.35 [95% CI, -0.54 to -12.16]; P = 0.047).
Secondary Outcomes
The study utilized the MDS-UPDRS-III and PDQ-39 as secondary outcome measures to evaluate the motor function and quality of life of the participants. In the experimental group, significant reductions in PDQ-39 scores were observed postintervention compared to preintervention (1.33 [95% CI, -0.35 to -2.51]; P = 0.036). In the control group, both the MDS-UPDRS-III and PDQ-39 scores decreased significantly from baseline (MDS-UPDRS-III: -0.84 [95% CI, -1.66 to 0.64]; P = 0.033; PDQ-39: 1.65 [95% CI, -1.66 to 2.64]; P = 0.046). At the end of the treatment period, there was no statistically significant difference in the improvement in the MDS-UPDRS-III and PDQ-39 scores between the two groups (MDS-UPDRS-III: 2.35 [95% CI, -6.35 to 11.05]; P = 0.588; PDQ-39: -1.56 [95% CI, -4.67 to 2.81]; P = 0.157).
Furthermore, the mental states of the participants were assessed using HAMD and HAMA scores. In the experimental group, there were significant reductions in both the HAMD and HAMA scores at the end of the treatment period (HAMD: -0.98 [95% CI, -1.31 to -1.67]; P = 0.042; HAMA: -1.59 [95% CI, -2.34 to -0.89]; P = 0.037). Compared to those in the control group, the reductions in HAMD and HAMA scores were statistically significant (HAMD: 0.32 [95% CI, 0.12 to 0.57]; P = 0.043; HAMA: 0.35 [95% CI, 0.08 to 0.77]; P = 0.031).
Tabel 2 Comparison of the Treatment Effects Between 2 Groups and Baseline
Outcome
|
Experimental group (n=25)
|
Control group(n=26)
|
Mean change from baseline
(95% CI)
|
P value
|
Mean change from baseline
(95% CI)
|
P value
|
FVC
|
-0.13(-0.24 to -0.01)
|
.029
|
0.36(-0.01 to 0.52)
|
.069
|
FEV1
|
-0.11(-0.18 to -0.02)
|
.015
|
-0.01(0.04 to 0.02)
|
.378
|
PEF
|
-0.14(-0.31 to -0.03)
|
.049
|
0.27(-0.01 to 0.56)
|
.054
|
MIP
|
-1.2(-4.02 to 1.61 )
|
.061
|
-2.3(-10.13 to 5.53)
|
.751
|
MEP
|
-0.13(-1.67 to -0.04)
|
.045
|
2.91(-0.95 to 6.75)
|
.132
|
MDS-UPDRS-Ⅲ
|
-0.31(-2.74 to 0.14)
|
.074
|
-0.84(-1.66 to -0.64)
|
.033
|
PDQ-39
|
-1.33(-0.35 to -2.51)
|
.036
|
-1.65(-1.66 to -2.64)
|
.046
|
HAMD
|
-0.98(-1.31 to -1.67)
|
.042
|
-0.71(-1.12 to 1.35)
|
.106
|
HAMA
|
-1.59(-2.34 to -0.89)
|
.037
|
-0.66(-2.38 to 1.13)
|
.269
|
Tabel 3 Comparison of outcomes Between Two Groups After treatment
Outcome
|
Experimental group (n=25)
|
Control group
(n=26)
|
Difference (95% CI)
|
P value
|
FVC
|
3.37(0.31)
|
2.86(0.32)
|
0.46(0.02 to 0.91)
|
0.003a
|
FEV1
|
2.63(0.17)
|
2.29(0.16)
|
0.33(0.01 to 0.76)
|
0.021a
|
PEF
|
5.75(1.86)
|
5.23(1.63)
|
0.27(-1.48 to 0.80)
|
0.053
|
MIP
|
57.35(20.43)
|
53.30(18.19)
|
1.95(-12.03 to 15.94)
|
0.398a
|
MEP
|
104.46(30.53)
|
95.05(27.02)
|
-5.35(-0.54 to -12.16)
|
0.047
|
MDS-UPDRS-Ⅲ
|
20.15(14.50)
|
20.30(12.62)
|
2.35(-6.35 to 11.05)
|
0.088
|
PDQ-39
|
19.33(12.53)
|
20.52(11.14)
|
-1.56(-4.67 to 2.81)
|
0.157
|
HAMD
|
6.58(5.67)
|
7.22(7.35)
|
0.32(0.12 to 0.57)
|
0.043
|
HAMA
|
6.09(4.89)
|
6.79(5.38)
|
0.35(0.08 to 0.77)
|
0.031
|
Adverse Events
One participant (4.0%) from the experimental group reported temporary mild backache, which resolved with the use of plaster. Two participants (7.7%) from the control group reported temporary mild knee pain when stretching but required no medical attention. No serious adverse events were reported.