Effect of Underwater Exercise on Lower-Extremity Function and Quality of Life in Post-Stroke Patients: A Pilot Controlled Clinical Trial

Abstract

Objectives:

To date, controlled clinical trials evaluating the efficacy of underwater exercise in improving the lower-extremity function and quality of life (QOL) in post-stroke patients have yet to be conducted. The purpose of the present study was to determine whether repeated underwater exercise enhances the therapeutic effect of conventional therapy for post-stroke patients.

Design:

This was a pilot controlled clinical trial.

Setting:

The study took place in a research facility attached to a rehabilitation hospital.

Patients:

This prospective trial included 120 consecutive post-stroke inpatients with hemiplegic lower limbs (Brunnstrom stage 3–6). Patients were assigned to either an experimental or a control group. Patients in the experimental group received both repeated underwater exercise and conventional rehabilitation therapy.

Interventions:

The underwater exercise consisted of 30-min training sessions in a pool with a water temperature of 30–31°C in which patients followed the directions and movements of trained staff. Training sessions were conducted once a day on 2 days of the week for a total of 24 times. Patients in the control group received only the conventional therapy.

Outcome measures:

The 10-Minute Walk Test (10MWT), the Modified Ashworth Scale, and the 36-Item Short Form Health Survey were the outcome measures used. Lower-extremity function and QOL were assessed before and upon completion of the 12-week program.

Results:

Improvements in 10MWT results and spasticity parameters were greater in the experimental group than they were in the control group (p < 0.01). Significant differences between the groups were observed in magnitudes of changes of all QOL parameters (p < 0.01).

Conclusions:

Combining conventional therapy with repeated underwater exercise may improve both lower-extremity function and QOL in post-stroke patients.

Introduction

Most stroke survivors suffer from motor, sensory, cognitive, perceptive, psychological, and social impairment.¹ Thus, approximately 50% of them require support from a caregiver.² Given the high prevalence of stroke and associated long-term disabilities worldwide, this creates an enormous economic burden.³

Hemiparesis—strictly defined as muscular weakness or partial paralysis of one side of the body—is present in three-quarters of stroke survivors. It has been proposed that slow walking speeds following stroke are causally related to an inability to generate sufficient lower-limb power to meet the task demands of body forward progression.⁴ Spasticity, a type of hypertonicity, is an increase in muscle tone due to hyperexcitability of the stretch reflex, and often inhibits volitional movement⁵; such inhibition subsequently affects muscle strength in the spastic limb.⁶ Therefore, it can be considered that the muscle strength of the lower extremity varies according to the spasticity. Decreased muscle-power generation means that the necessary mechanical energy for the trunk and legs may not be available, thereby negatively affecting walking performance⁷ and reducing functional independence and quality of life (QOL).⁸ Accordingly, one of the main purposes of treatment for post-stroke patients is to improve certain lower-extremity functions, such as walking ability, and ameliorate spasticity.⁶ Enhanced lower-extremity functions can expand patients' functional participation in activities of daily living (ADL) and improve QOL.

As various kinds of rehabilitation therapies, such as orthotic devices, robotics, and functional electrical stimulation, have come into wide use in recent years, the number of post-stroke patients who can live in a stable condition for many years has increased. Recently, underwater exercise has received increased attention⁹ as a technique capable of satisfying the social demands for more effective and safer therapeutic interventions in stroke rehabilitation. In particular, it is one of the most effective interventions for improving balance,¹⁰ walking ability,^11,12 range of motion (ROM),¹³ and exercise tolerance and for reducing fatigue in most post-stroke patients.¹⁴ Therefore, large positive effects can be expected from underwater training.^15
–17 Furthermore, it has been found previously that immersion into warm water for 10–15 min suppresses muscle spasticity in post-stroke patients.^18,19 Pilot data suggested that such thermotherapy alleviates the abnormally elevated muscle tone without any side effects.^20,21 Despite these advantages of underwater exercise, this approach has not been thoroughly investigated, and previous reports have not focused on the relationship between lower-extremity function and QOL.²⁰

The present study was conducted to determine whether repeated underwater exercise can enhance the effect of conventional therapy in such patients.

Materials and Methods

Patients

This prospective study was conducted on 120 consecutive inpatients (88 males) who had been diagnosed with lower-limb hemiplegia due to stroke. The diagnosis of stroke was based on results of computed tomography (CT) or magnetic resonance imaging (MRI), as well as examination of neurological functions.

The inclusion criteria were as follows: age between 20 and 75 years; presence of hemiplegia of a lower limb (Brunnstrom stage²¹ 3–6); and ability to walk without assistance using a T-cane and/or ankle-foot orthosis. The exclusion criteria were as follows: within 4 weeks from the onset of stroke; abnormal gait prior to the onset of stroke (e.g., because of joint disability or peripheral neuropathy); any medical condition that limited underwater exercise (such as severe cardiopulmonary disease, severe sensory disturbance, or severe hypertension); severe aphasia that made it impossible to follow verbal instructions; lesions on both sides of the cerebral hemisphere; and dementia that interfered with the outcome assessments.

Study protocol

The present study had a prospective, observer-blinded, open-label, controlled design. The number of patients necessary for the study was calculated a priori. According to a meta-analysis,²² the minimal effect size for therapy affecting lower-extremity function in post-stroke patients should be 0.60. Therefore, a sample of 50 patients is needed to ensure an 80% probability (β = 0.20) of detecting a 20% difference (α = 0.05) between two treatment groups. To account for possible dropouts, a 120 patients were enrolled in the study. The post-stroke patients were nonrandomly assigned (alternately with respect to the enrollment sequence) to either the experimental group or the control group. The patients in the experimental group performed repeated underwater exercise and underwent conventional rehabilitation therapy. The patients in the control group underwent conventional rehabilitation therapy in the same manner as the experimental group, but did not perform underwater exercise. The assignment was conducted by a physician who was not involved in the enrollment process. This physician explained the study protocol to the patients and obtained their written informed consent prior to assigning the patients to one of the two groups. The evaluator tasked with estimating the therapeutic effect in all patients (experimental and control group) was a trained physiotherapist who had no other involvement in the study and served as a blinded observer.

The study was conducted without altering the existing medication regimes of the patients. The procedures used in this study complied with the 1975 Declaration of Helsinki, as revised in 2013. This study was carried out with the permission of the Ethical Committee of Kagoshima University.

Underwater exercise

The underwater exercise was performed according to the guidelines of the Japanese Association of Physical Medicine, Balneology, and Climatology. A pool (48,000 L volume, 4 m width, 8 m length, 1.5 m depth) was prepared, and each patient was immersed in water up to the chest level, which corresponds to the patient's xiphoid process sterni. Underwater exercise was defined as a session consisting of aerobic exercise involving various types of movement in a warm treatment pool.

The patients performed the underwater exercise by following verbal instructions, as well as following the movements demonstrated by a group of five physiotherapists. The exercise protocol consisted of 30 min, with a 5-min warm-up and flexibility exercises, 20-min endurance and strength exercises based on walking, and a 5-min cool-down. The program aimed at improving endurance, postural control, flexibility, mobility, and walking in water and reducing symptoms such as daytime fatigue, exhaustion, and tiredness.²⁰ In the first week, warming-up, stretching, and walking forward, side, and back were performed to music. In addition, rubber-tube devices were used for exercise of both leg abduction and adduction muscles. In the second week, complicated exercises, including recreation, dancing to music, abdominal twists, and elbows to knees, were performed in addition to the first-week protocol. In the third week, resistance exercise with abdominal muscles as twisting knee up, hold knee, and kicking to front were performed in addition to the second-week protocol. During weeks 4–12, based on the third-week protocol, walking with long strides, abdominal twists, kicking to the front, rubber-tube exercise, and recreation were performed. Underwater exercise sessions were carried out in a treatment pool with a water temperature of 30–31°C for 30 min at the same time of day (13:30–14:30) after a meal. The exercise was performed once a day on 2 days of the week (Monday and Thursday) for 12 weeks, for a total of 24 times.²³

Conventional rehabilitation therapy

All the patients underwent a conventional stroke rehabilitation program that started up to 2 weeks before this study. The conventional rehabilitation treatment was conducted six times per week and included ROM exercises, muscle strengthening, and basic activity training usual gait and ADL training and speech therapy. The patients were instructed not to change their program during this study.

Estimation of therapeutic effect

Three rehabilitation parameters (two lower-extremity function measures and one QOL indicator) were measured at baseline and after the completion of the study. The term ‘lower-extremity function’ was further defined as an overall indicator of walking speed, cadence, and extent of spasticity. Evaluators were blinded to a patient's treatment assignment, and patients were unaware of the study's hypotheses.

First, the 10-Minute Walk Test (10MWT) was used to assess walking ability.²⁴ Patients were instructed to walk at a comfortable speed over a standardized 10-m distance. A stopwatch was used for timing, and a counter was used to obtain the number of steps. To eliminate acceleration and deceleration periods, patients started and stopped walking 2 m before and beyond the walkway, respectively.²⁵ Each patient performed a practice trial followed by two timed trials. The data were converted to determine the comfortable walking speed (m/min) and cadence (steps/min). The times of the two trials were averaged and used for statistical analysis.

Second, the extent of spasticity was measured using the Modified Ashworth Scale (MAS) score²⁶ for the triceps surae muscle of the calf, which has a correlation with gait ability. The MAS is an established and widely used clinical test, which uses a six-point scale to score the average resistance to passive movement for each joint. A MAS score of 0 indicates no increase in muscle tone, while a MAS score of 4 indicates that the affected part(s) is rigid in flexion or extension. To facilitate data analysis, the MAS scores (0, 1, 1+, 2, 3, and 4) were assigned numerical values designated as “computed MAS scores” (0, 1, 2, 3, 4, and 5).^27,28 Changes in MAS scores were calculated by subtraction.

Third, the QOL was evaluated based on the 36-Item Short Form Health Survey (SF-36).^29,30 The Japanese version of the SF-36 generic health-related QOL scale was used in this study.³¹ SF-36 is a reliable and valid measure to assess health-related QOL in the Japanese population.³¹ SF-36 is a widely used and validated scale that yields a score for the following eight aspects of health-related QOL: (1) physical functioning (PF), which pertains to limitations of physical activities, such as self-care, walking, and climbing stairs, caused by health problems; (2) role-physical (RP), which describes interference with work or ADL due to physical health; (3) bodily pain (BP), which assesses pain intensity and how it affects inside and outside activities; (4) general health (GH), which evaluates overall health; (5) vitality (VT), which describes the level of energy; (6) social functioning (SF), which determines how much a patient's health interferes with social interactions; (7) role-emotional (RE), which assesses limitations to work or ADL caused by emotional health; and (8) mental health (MH), which evaluates overall emotional and psychological status. In this clinical trial, the improvement of QOL was evaluated separately for each domain of the SF-36 according to the criteria reported by Fukuhara et al.³¹ in an attempt to avoid using simple average scores without clinical meaning. Moreover, summary measurements such as overall physical health (physical component summary [PCS]) and mental health (mental component summary [MCS]) scores were also assessed. Each component of the SF-36 questionnaire was analyzed using the standard scoring system provided with the questionnaire. Scores ranged from 0 to 100 for each component, with 0 indicating the worst possible health status and 100 indicating the best.

Statistical analysis

All data were expressed as absolute values, means ± standard deviation (SD), or median values (25th–75th percentiles). The unpaired t-test or Mann–Whitney U-test was used for comparison between the groups. The statistical analysis was performed using PASW Statistics for Windows v18.0 (SPSS, Inc., Chicago, IL), and a p-value of <0.05 was considered to indicate statistical significance.

Results

All the patients successfully completed the 12-week study program comprising conventional rehabilitation therapy and underwater exercise (100% patient compliance). The underwater exercise was tolerated well, and no complications or severe or fatal adverse events were observed.

Patient demographic characteristics

Table 1 shows the demographic characteristics and degrees of severity of neurological impairment of the post-stroke patients. No substantial differences were observed between the two groups at baseline in terms of age, sex, diagnosis, site of lesion, time since onset of stroke, hemiplegic side, Brunnstrom stage, and Barthel index (Table 1).

Table 1.

Baseline Characteristics of the Study Groups

	Experimental group (N = 60)	Control group (N = 60)	p-Value
Age, years	62.4 ± 10.7	63.2 ± 11.5	0.32
Men/women	42/18	46/14	0.81
Diagnosis			0.70
Cerebral infarction	41	39
Intracranial hemorrhage	19	21
Site of lesion			0.46
Cortical	24	28
Subcortical	36	32
Cerebellar/brainstem	0	0
Initiation of intervention from onset, weeks	22.8 ± 14.4	24.8 ± 12.7	0.35
Side of hemiplegia (right/left)	28/32	24/36	0.46
Brunnstrom stage
Upper limb	3.5 (3–4)	3.5 (3–4)	0.66
Hand	3.0 (2–4)	3.0 (2–4)	0.72
Lower limb	4.0 (3–5)	4.0 (3–5)	0.47
Barthel index	65 (55–75)	70 (55–85)	0.36

Data are absolute numbers presented as means ± SD or median values (25th–75th percentiles).

SD, standard deviation.

Lower-extremity function—walking ability and spasticity

Table 2 summarizes the changes in 10MWT results and MAS scores after each intervention. Both speed and cadence changed significantly in both the experimental group and control group. The mean MAS score was significantly reduced in the experimental group after the treatment with underwater exercise (2.1 at baseline vs. 1.4 after treatment, p < 0.0001) but not in the control group.

Table 2.

Changes in the 10MWT Results and MAS score

	Experimental group (N = 60)			Control group (N = 60)
	Baseline	End of treatment	p-Value	Baseline	End of treatment	p-Value
10MWT
Speed (m/min)	31.2 ± 10.5	34.3 ± 10.6	<0.0001	31.9 ± 10.3	33.0 ± 10.4	0.0049
Cadence (steps/min)	86.5 ± 18.1	90.5 ± 17.7	<0.0001	88.7 ± 17.4	90.7 ± 17.1	0.0051
MAS score	2.1 ± 0.9	1.4 ± 0.8	<0.0001	2.2 ± 0.8	2.3 ± 0.8	0.5824
	2.0, 1.0–3.0 (1–4)	1.0, 0–2.0 (0–2)		2.0, 1.0–3.0 (1–4)	2.0, 1.0–3.0 (1–4)

Data are absolute numbers presented as means ± SD. All data are presented as the mean ± SD or the median and quartiles (range).

10MWT, 10-Meter Walk Test; MAS, modified Ashworth scale.

The mean 10-m walk speed increased by 3.09 m/min in the experimental group and by 1.12 m/min in the control group, and the difference was statistically significant (p = 0.0008; Table 3). A statistically significant difference between these two groups was also found for the mean change in 10-m walk cadence (p < 0.01; Table 3), which increased by 4.07 steps/min and 2.04 steps/min in the experimental and control groups, respectively. The mean MAS score decreased by 0.7 in the experimental group and increased by 0.1 in the control group (p < 0.0001; Table 3).

Table 3.

Comparison of the Mean Differences in Parameters at Baseline and at the End of the Study Between the Study and Control Groups

	Mean difference
	Experimental group	Control group	p-Value
10MWT
Speed (m/min)	3.09 ± 3.74	1.12 ± 2.49	0.0008
Cadence (steps/min)	4.07 ± 4.42	2.04 ± 4.32	0.0067
MAS score	0.7 ± 0.6	0.1 ± 0.7	<0.0001
	1.0, 0–2.0 (0–2)	0, 0–1.0 (0–1)

Data are absolute numbers presented as means ± SD. All data are presented as the mean ± SD or the median and quartiles (range).

QOL

Table 4 shows the changes in QOL parameters at baseline and after 12 weeks. In the experimental group, the treatment resulted in statistically significant improvements in QOL manifested by changes in all the eight domains of the SF-36 and overall physical and mental component summary scores (p < 0.0001). In contrast, such improvements were observed in only five of the eight domains in the control group. The mean PCS and MCS scores significantly increased after the treatment in the experimental group (PCS score: from 25.5 to 41.0, p < 0.0001; MCS score: from 34.1 to 47.6, p < 0.0001) but not in the control group.

Table 4.

Changes in the QOL Parameters

	Experimental group (N = 60)			Control group (N = 60)
	Baseline	End of treatment	p-Value	Baseline	End of treatment	p-Value
Physical functioning (PF)	14.2 ± 15.0	38.9 ± 14.7	<0.0001	14.1 ± 17.7	27.0 ± 16.3	<0.0001
Role-physical (RP)	17.8 ± 13.8	34.3 ± 12.5	<0.0001	17.9 ± 14.3	22.1 ± 14.4	0.0159
Bodily pain (BP)	35.3 ± 9.9	47.4 ± 10.5	<0.0001	34.0 ± 9.3	37.7 ± 9.7	0.0155
General health (GH)	34.7 ± 9.8	43.3 ± 11.2	<0.0001	35.7 ± 12.3	37.4 ± 12.1	0.4360
Vitality (VT)	38.1 ± 8.7	51.9 ± 8.8	<0.0001	37.4 ± 10.6	42.9 ± 10.7	0.0023
Social functioning (SF)	29.5 ± 17.6	43.1 ± 14.5	<0.0001	28.5 ± 14.4	33.1 ± 14.3	0.0419
Role-emotional (RE)	31.3 ± 16.5	44.5 ± 12.1	<0.0001	31.3 ± 18.8	32.8 ± 17.4	0.5888
Mental health (MH)	37.3 ± 11.9	50.8 ± 8.0	<0.0001	37.3 ± 12.7	39.6 ± 12.0	0.3226

Data are absolute numbers presented as means ± SD.

QOL, quality of life.

Significant differences between the groups were observed in the magnitudes of changes of all QOL parameters (eight domains of the SF-36, PCS, and MCS; p < 0.01; Table 5).

Table 5.

Comparison of the Mean Differences in the QOL Parameters at Baseline and at the End of the Study Between the Study and Control Groups

	Mean difference
	Experimental group	Control group	p-Value
Physical functioning	24.7 ± 13.8	12.9 ± 20.3	0.0002
Role-physical	16.5 ± 12.5	4.1 ± 12.4	<0.0001
Bodily pain	12.1 ± 10.5	3.7 ± 11.3	<0.0001
General health	8.6 ± 9.8	1.6 ± 16.1	0.0007
Vitality	13.8 ± 10.7	5.5 ± 13.3	0.0003
Social functioning	13.6 ± 15.2	4.6 ± 15.6	0.0067
Role-emotional	13.2 ± 15.1	1.6 ± 20.8	0.0011
Mental health	13.5 ± 10.8	2.3 ± 16.4	<0.0001

Data are absolute numbers presented as means ± SD.

Discussion

The goal of this study was to evaluate the effect of underwater exercise in post-stroke patients. The changes in 10MWT results, MAS score, and SF-36 score in the experimental group were statistically greater than those in the control group. Notably, significant between-group differences were observed in the magnitudes of changes for all these measurements. These results indicate that the combination of repeated underwater exercise and conventional rehabilitation therapy may enhance lower-extremity function, thereby improving QOL in patients with stroke, which is beneficial for comprehensive stroke treatment.

Stroke is characterized by hemiplegia and gait impairment. In particular, low walking speed is the most consistently observed gait impairment following stroke. Importantly, improving walking speed is (1) independently related to overall health status, (2) a strong predictor of functional recovery, (3) reflective of both physiological and functional changes, and (4) the most often-stated goal during rehabilitation therapy.³² Therefore, interventions aimed at improving functional walking status are critical for enhancing the QOL for hemiplegic individuals and their caregivers. This study demonstrates that the larger improvement of lower-extremity function (i.e., walking ability and spasticity) after repeated underwater exercise not only reflects increased muscle activity and strength^33,34 along with muscle tone suppression by the thermotherapy,^18,19,35 but also indicates enhanced QOL.

The effectiveness of underwater interventions is well established in the elderly population^36,37 as well as stroke patients.^38
–40 Such low-risk exercise helps post-stroke patients to improve motor ability safely and comfortably by providing support to the body and reducing the fear of falling and possibility of sudden injury.⁴¹ Additionally, the viscosity and drag force of this environment can reduce the velocity-dependent spastic response.⁷ Previous studies have reported that repeated underwater exercise improves walking speed, paretic lower-extremity strength, and even psychological measures such as depression and anxiety. In addition, the properties of water can provide various benefits for gait training. Thus, the amount of support can be regulated by changing water level and, consequently, the Archimedes force.³⁶ This allows individuals who have difficulty with gait training on the ground to practice walking in a supporting environment without the fear of falling.⁴²

Spasticity is observed in the majority of post-stroke patients, and it can be associated with pain and poor health status,⁴³ especially in the lower limbs. There are several thermotherapy techniques for the treatment of spasticity,⁴⁴ of which one is underwater exercise. Thermotherapy is thought to have antispastic effects that are not only due to relaxation of muscles and other soft tissues but are also caused by a decrease in gamma-afferent fiber activity through a nervous system response.^45,46 This process is believed to reduce spasticity and pain, which leads to increased scores in some domains of the SF-36, especially in BP, VT, and GH.

This study has some limitations. First, the sample size was small, and future studies with a larger number of patients are needed to confirm the results. Second, an obvious selection bias was present because the study was not randomized. The therapeutic outcome of underwater exercise might have been biased because these patients received more attention and they were aware of the purpose of the study, thus potentially anticipating certain effects. Further studies with a more rigorous methodological design are warranted in order to characterize the individual effect of underwater exercise. Finally, further studies are needed to investigate not only lower-extremity function and QOL, but also changes in muscle strength or balance or psychological measures in order to understand the mechanism of improvement of both the physical and mental components of QOL. The investigation of changes in muscle strength or psychological measures before and after repeated underwater exercise may provide insight into the association between repeated underwater exercise and QOL.

In conclusion, this study provides new information on the effect of repeated underwater exercise in patients with stroke. The results show that the addition of repeated underwater exercise to conventional rehabilitation therapy for post-stroke patients could lead to faster and more efficient recovery of the lower-extremity function as well as QOL improvement.

Footnotes

Author Disclosure Statement

The authors report no conflicts of interest with regard to this work.

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