Adherence to a home physical exercise program in patients with osteoporotic vertebral fractures: A retrospective observational study

Abstract

BACKGROUND:

Adherence to treatment is one of the most common problems in patients suffering from chronic disease such as osteoporosis, and special commitment is required to patients, especially regarding rehabilitation. There is increasing evidence that physical interventions aimed at relieving pain and reducing physical impairments could play a crucial role in improving the quality of life and reducing the risk of fractures in patients with severe osteoporosis.

OBJECTIVE:

The aim of this study was to assess the compliance and determine the acceptability of a home-self-managed exercises program in patients with vertebral fractures, one of the most frequent and serious consequences of osteoporosis.

METHODS:

We conducted a retrospective observational study of patients undergoing a home exercise program, monitoring them with clinical scales, questionnaires, and routine visits.

RESULTS:

62.86% of the patients were compliant with the treatment; the absence of supervision by health personnel was the primary cause of non-compliance, followed by the lack of time and the lack of motivation. Compliant patients showed a significant reduction in lumbar pain ( $p$ 0.011), an improvement in posture with a reduction of dorsal kyphosis (occipital-wall distance T0-T1, $p$ -value $=$ 0.02) and an improvement in QoL ( $p$ -value $=$ 0.001) and physical performance at the 20 m walking test ( $p$ -value $=$ 0.003).

CONCLUSIONS:

A home exercise program is feasible and could improve signs and symptoms in patients with vertebral fractures due to OP.

Keywords

Compliance physical exercise vertebral fractures osteoporosis

1. Introduction

Osteoporosis (OP) represents a major public health problem that impacts social activities. OP is emerging throughout Europe, due to the progressive and constant aging of the population [1] and is associated with an increased risk of fractures, leading to a high risk of disability, hospitalization, and mortality in the elderly [2].

Vertebral fractures are among the most frequent and severe osteoporotic fractures. Commonly, vertebral fractures coming to clinical attention have severe posture consequences, including thoracic iperkyphosis, head protrusion, and knee flection. Moreover, osteoporotic vertebral fractures can cause pain, limitation of activities and social participation, altered mood, increased risk of falls. Therefore, these patients experience a significant impact on morbidity, disability, and mortality, with reduced autonomy and quality of life (QoL) and have an increased risk of further fractures [3].

There is increasing evidence that physiotherapy interventions, aimed at relieving pain and improving physical impairments, may have a crucial role in improving QoL and reducing risk of fractures in severe osteoporotic patients. In Literature, there are several randomized controlled trials focused on exercise interventions in people with vertebral fractures, reporting beneficial effect in terms of pain reduction and improvement of mobility, balance and QoL [4, 5, 6, 7].

Adherence to treatment is one of the most common problems in patients with chronic disease such as OP; in fact, a particular commitment on the part of patients is required, especially as regards rehabilitation. Exercise programs, both at home and in the outpatient settings, are the standard of care for musculoskeletal disorders, including OP, and patient compliance is key to increasing the effectiveness of physical treatment [8]. Despite the benefits of these programs, patients have been found to adhere only 50% of the time in clinical setting [9] and even less to adhere to home exercise instructions [10, 11].

The aim of this study was to assess compliance and determine the acceptability of a home-self-managed exercise program in patients with vertebral fractures. Second, we investigated the effects and the level of impact of the program on the overall patient outcome.

2. Materials and methods

We conducted a retrospective observational study on the data collected at the multidisciplinary clinic for “Diagnosis, Therapy and Rehabilitation of patients with vertebral fragility fracture” of the University of Pisa. At the first visit, informed consent, on the collection and processing of data, was obtained by all subjects. The analysis was conducted on properly anonymized data, collected in databases shared by the specialists of the multidisciplinary clinic. The retrospective observational nature of the study, which was performed on data collected during the routine follow-up visit, did not require ethical approval.

We collected data from 35 patients attending the outpatient clinic, excluding uncooperative patients, patients with recent fracture ( $<$ 3 months), patients using any kind of corset or orthosis, and patients unable to walk independently.

During the routine clinical visit, all patients underwent a baseline assessment and received a tailored exercise program executable at home, according to their general health.

All patients were being treated for OP and used analgesic drugs as needed. The treatment consisted of vitamin D and calcium supplementation for all patients and specific OP treatment with bisphosphonate or Denosumab.

Clinical evaluation was performed at baseline (T0) and after 6 months (T1). Age, gender, and medical history, including the location and level of vertebral fractures, were obtained at baseline.

During the routine appointment:

•
patients were asked to rate back pain in activity and at rest, using a 10-point visual analogue scale (VAS) for dorsal and lumbar pain;
•
patients performed a 20 meters walking test for disability;
•
patients completed the Italian version of EuroQuol-5D (EQ5D) to assess QoL [12];
•
patients’ height and occipital-wall distance were measured.

At the end of the first visit, each patient received a booklet containing the self-administered home physical exercise program. The program was tailored to patients with vertebral fractures, containing exercises aimed to improve pain control, patient’s autonomy and QoL. The physical exercises have been studied and modified after a careful evaluation by doctors and physiotherapists. The program consisted of 10 exercises in lying position, 5 exercises in sitting position and 3 exercises in standing position. The program included active stretching, balance and strength training. The entire program lasted about 60 minutes and has been recommended at least for 40 minutes a day, three days a week. Specified exercises are summarized in the Appendix.

At the 6 months (T1), all patients answered a questionnaire, investigating their adherence to the program.

Based on the first 5 items of the questionnaire, patients were divided in two different groups: Compliant patients (Group A) and Non-Compliant patients (Group B). Group A replied to five more questions, regarding training features (duration, frequency, difficulty). Group B answered four further items exploring the reasons for non-adherence.
2.1 Statistical analysis

The outcome measures were preliminarily analysed by descriptive statistics, through the calculation of the main statistical indices of position, dispersion and shape (Average, Mediana, Dev. Standard, Min, Max).

Later both demographic and clinical data were tested for normality by the Shapiro-Wilk normality test. The test confirmed that the selected measures are distributed in not-normal way.

The Wilcoxon test was performed to evaluate the significance of the differences obtained between first and control visit in compliant patients, placing a level of significance equal to 5% ( $p$ -value $=$ 0.05). Similarly, the Wilcoxon test was used to compare outcome measures of non-compliant patients at T0 and T1.

3. Results

The first part of the questionnaire allowed the identification of two above mentioned groups: the 62.86% of the sample (Group A – 22 pts) was compliant with the treatment, while the 37.14% (Group B – 13 pts) did not follow the program.

In Group B, the 61.54% of the patients identified the absence of supervision by health personnel as a primary cause of non-compliance. The 30.77% of the group declared that the main factor of reduced adherence to treatment was the lack of time, while the remaining 7.69% of the group reported lack of motivation.

In Group A, the 27.27% carried out the self-managed home-exercise program for about 1 month. The 13.64% of the sample continued for about 3 months, and the remaining 59.09% had been carrying out the exercise program until the end of the study period (6 months – T1).

More than 50% of the patients adhered to the recommended frequency of 3 or more weekly sessions; Particularly, the 22.73% practiced four days a week and the 31.82% for seven days a week. The 36.36% of Group A reported having performed the exercise program with a frequency of 2 days a week; the 9.09% performed the program only once a week.

The 59.09% of the patients was compliant to the suggested duration of the exercise session (at least 30 minutes a day). Specifically, 27.27% exercised daily for 60 minutes, the 31.82% for at least 30 minutes. The 40.91% of the patients did not follow the recommended training duration as they performed the exercise program less than 15 minutes a day.

In Group A, data analysis highlighted an improvement of pain on the investigated sites: dorsal VAS scale decreased by an average of 24.21%, lumbar VAS decreased by 26.13%. The average height in Group A increased by 38.21%, passing from T0 $=$ 158 cm to T1 $=$ 158.5 cm. Regarding the occipital-wall distance, there was a reduction in the average distance of 21.35%. The walking test showed an improvement too: the 20 m travel time decreased by 10.60%, passing from an average of T0 $=$ 28.1 s to T1 $=$ 25.03 s. The result of the questionnaire of QoL (Eq-5D Index) demonstrated a general improvement of the score values after treatment, up to 50.57%, from an average of 0.457 to 0.688 (Table 1).

Table 1
Data analysis in Group A – Compliant patients

	T0	T1	$\Delta$
Dorsal pain – VAS	4.13	3.13	$-$ 1
Lumbar pain – VAS	4.86	3.59	$-$ 1.7
Height (cm)	158	158.5	$+$ 0.6
Occipital-wall distance (cm)	8.43	6.63	$-$ 1.8
20 m walking test (s)	28.1	25.03	$-$ 2.98
Eq-5D index	0.457	0.688	$+$ 0.231

Table 2

Data analysis in Group B – Noncompliant patients

	T0	T1	$\Delta$
Dorsal pain – VAS	2	3.38	$+$ 1.38
Lumbar pain – VAS	5.53	5.53	0
Height (cm)	154.7	153.7	$-$ 1
Occipital-wall distance (cm)	8.61	9.19	$+$ 0.58
20 m walking test (s)	32.177	31.95	$-$ 0.227
Eq-5D index	0.498	0.436	$-$ 0.062

Outcome measures variations of Group B at T0 and T1 are shown in Table 2. Patients in Group B experienced worsening of dorsal pain, the value of the dorsal VAS scale increased by an average of 69%, while the lumbar VAS remained unchanged. With regards to height, there was a slight reduction with a mean decrease of 0.7%, passing from T0 $=$ 154.7 cm to T1 $=$ 153.7 cm. In the noncompliant patients, the occipital-wall distance increased by 6.73%. When performing the walking test, the travel time of 20 m was slightly reduced of 0.70% (T0 $=$ 32.177 sec, T1 $=$ 31.95 sec). Regarding the QoL there was a general worsening of the 12.45% at the Eq-5D Index score (Table 2).

Table 3

$P$ -value calculated by Wilcoxon test for dorsal pain in Groups A and B

	Group A ( $p$ -value)	Group B ( $p$ -value)
Dorsal pain VAS T1-T0	0.06	0.071
Lumbar pain VAS T1-T0	0.011	1.00
Height T1-T0	0.072	0.044
Occipital-wall distance T1-T0	0.02	0.443
20 m walking test T1-T0	0.003	0.861
Eq-5D index T1-T0	0.001	0.197

Table 3 shows the p-values of the outcome measures obtained in each group at baseline and after 6 months (Table 3). In compliant patients, the analysis showed a significant improvement. There was a decrement in lumbar VAS ( $p$ -value $=$ 0.011), a reduction in the occipital-wall distance ( $p$ -value $=$ 0.02), a significant improvement of the 20 m walking test ( $p$ -value $=$ 0.003) and a significant increase in the QoL ( $p$ -value $=$ 0.001). Our data demonstrated a trend of improvement in dorsal VAS and a height gain, although there was no statistical significance.

In non-compliant patients, there was an increase in pain symptoms in the two investigated sites, a raise of the occipital-wall distance, a worse performance in the 20 m walking-test and a reduction of the Eq5d index. None of the above-mentioned variations was statistically significant. However, a significant difference is found in height: non-compliant patient showed a stature reduction ( $p$ -value $=$ 0.044).

4. Discussion

OP and vertebral fractures have a significant impact on QoL, due to pain, limitation in activities and social participation, often associated with altered mood. The need to develop effective treatment approaches for OP and to decrease the health burden of vertebral fractures is an important clinical and research objective.

The association of a physiotherapy program with common conservative treatments for OP, determines the best results. However, in patient with vertebral fractures it is often necessary to emphasize the benefits of mobilization and overcome their concerns about potential risks of physical exercise.

The introduction of a home exercise program has the advantage of being acceptable for the patient allowing a maximization of therapeutic results. A randomized controlled study in 80 postmenopausal women with OP investigated the effect of a home-based, simple, low-intensity exercise protocol showing an improvement in the QoL and back extensor strength [13]. Our results confirmed the effectiveness of an exercise home program in OP patients with associated vertebral fracture. In fact, the group of compliant patients presented an improvement in the average score of the Eq-5D items regarding the QoL. Moreover, in our sample we found an improvement of pain symptoms, anthropometric parameters (height and occipital-wall distance) and walking test performance.

Although several studies have shown the efficacy of physical rehabilitation in OP patients, the problem of compliance remains a critical issue. Poor adherence to physiotherapy is a problem with up to 65% of patients being either non-adherent or partially adherent to their home programs [10]. Compared to the literature, our study showed a similar percentage of patients with poor compliance to physiotherapy: the patients completely non-adherent to the treatment were the 37.1%. Poor adherence to long-term therapies severely compromises the effectiveness of treatment, making this a critical issue in population health, above all about QoL.

Interventions aimed at improving adherence would provide a significant positive return on investment through primary prevention and secondary prevention [14]. Therefore, it is necessary put in place strategies to favour the adherence to long-term rehabilitation treatment.

Researching into patient adherence with medication adherence means improving health and reducing negative financial, physical and emotional consequences within society [15, 16]. Research into this area has been prolific, with investigations focused on predictive factors of adherence, and the assessment of specific interventions to improve it [17, 18].

Despite studying compliance to prescribed home rehabilitation exercises have the same rationale, surprisingly, there is a dearth of published research about factors related to adherence to home-rehabilitation [10] and even less about successful interventions to improve it [19]. The reported rates of non-adherence are similar to medication: 50% on medication non-adherence [15, 16] compared to 50–65% of home rehabilitation exercises non-adherence [10, 20].

Treatment abandonment can be due to various causes: lack of motivation or interest, cause of force majeure as logistic issues, aggravation of the state of health [21]. In our study, most patients perceived the absence of health supervision of a self-managed home program as negative.

To solve the problem of lack of supervision in a self-managed home exercise program, education of patients and relatives could be useful. For instance, engaging patient’s family in promotion of compliance might improve patient adherence and outcomes. Another strategy could be the use of telephone follow-up, where the therapist provides support, verifies adherence to the program and identifies further areas for interventions. In addition, to improve patient involvement, it is important to provide all the tools to monitor the care path. For example, it could be useful to keep a diary to record time of exercise, concerns, adverse effects, significant improvements and changes in objective measures. A physical therapy diary could be a fundamental tool both for the patient and the health professional as it might both improve patient’s awareness of achievements and highlight the main criticalities, allowing an adaptation of the treatment to the patient’s feedback.

Although in a limited number of patients, this study demonstrated that a home-managed exercise program results in an improvement in symptoms and QoL for patients with OP and vertebral fractures. This highlighted the need to implement this approach in the management of this condition. Naturally, the exercise program cannot be separated from a specific drug therapy which, if not corrected, could in turn determine a lack of adherence to the physical treatment. Unfortunately, the data at our disposal did not allow a stratified analysis based on the drugs used, also because this went beyond the specific aim of the study. Further research and studies are needed to support the data highlighted, allowing to emphasise other elements of non-adherence to the treatment as well as measures that can increase adherence.

5. Conclusion

The present study suggests that home exercise program could improve signs and symptoms in patients with vertebral fractures due to OP. However, it has been found that there is a low adherence to physiotherapy treatment due, in most cases, to lack of supervision. Clinicians should assess and recognize the barriers to patient rehabilitation adherence, especially for exercises managed at home. Our future goals are to identify individual factors that can impact on adherence to home rehabilitation programs and to define strategies aimed to implement compliance, thus allowing a personalized therapeutic approach in patients with vertebral fragility fractures.

Footnotes

Conflict of interest

None to report.

Appendix: Home exercise program

Lie down in Supine position:

Deep breathing: “Take a deep breath, inhaling with the nose and exhaling with the mouth. 10 repetitions”.

Reduction of dorsal kyphosis: “Press your shoulders against the floor closing the shoulders. Maintain contraction for 5 sec then relax. 10 repetitions”.

Anterior elevation of the upper limbs: “Raise both arms upward, stretching them back and keeping the back well adherent to the floor, then return to the starting position. 10 repetitions”.

Alternate elevation of the upper limbs: “Raise one arm at a time, stretching it, keeping the back snug to the floor. 10 repetitions”.

Abduction of the upper limb with elbow flexed at 90 ${}^{\circ}$ : “Open your arms at elbow flexion, up to reach shoulder height. Then go back to the starting position. 10 repetitions”.

Isometric abdominals reinforcement: “Contract your abs without moving shoulders. Hold the contraction for 3–4 second, then relax. 10 repetitions”.

Alternating hip flexion associated with abdominal isometric contraction: “Bring one knee at a time to your chest; hold the position for 3–4 seconds and return to the starting position. 10 repetitions”.

Bridge with buttocks and abdominal contraction: “By simultaneously contracting the abdominals and buttocks lift the pelvis off the bed. Hold the position for 3 seconds and relax. 10 repetitions”.

Alternating extension of the knee with semi-flexed hip: “Position the legs with the knee flexed on a chair so that a hip and knee flexion of approximately 60 ${}^{\circ}$ is achieved. Stretch one leg at a time keeping the knee in contact with the chair and keeping the ankle at 90 ${}^{\circ}$ . 10 repetitions”.

10.

Knee extension “Extend the lower limb alternating right and left, touching the heel on the ground. 10 repetitions”.

Exercises in a sitting position:

Spine realignment: “Stretch the spine from the lumbar to the cervical, bringing the nape up and the chin back. Hold the stretch position for 3–4 seconds and then relax. 10 repetitions”.

Shoulder retropulsion: “Bring the shoulders back, closing the shoulder blades posteriorly. Hold the contraction for 3–4 seconds, then relax. 10 repetitions”.

Shoulder Elevation: “Raise the shoulders and hold the contraction for 3–4 seconds with the head and neck in the starting position, then relax. 10 repetitions”.

Flexion and extension of the trunk: “Tilt the torso back and forth slowly, shifting your weight without moving your shoulders and feet, keeping your back straight. 10 repetitions”.

Proprioceptive exercise: “Slowly shift your weight from the right to the left buttock without moving your shoulders and feet. 10 repetitions”.

Exercises in standing position:

Shoulder flexion under natural load up to 90 ${}^{\circ}$ with the dorsal spine leaning against the wall: “Raise the arms upwards, keeping both the spine and the shoulder blades in good contact with the wall. 10 repetitions”.

Shoulder retropulsion: “Close the shoulder blades posteriorly by bringing the shoulders back and maintaining contact with the wall. 10 repetitions”.

Isometric extension of the shoulders with forearm pronated and hands against the wall: “Push with the forearm on the wall, maintaining the contraction for 3–4 seconds and the back well adherent to the wall. 10 repetitions”.

All exercises must be performed in the absence of pain and it is recommended to rest at least 1–2 minutes after each exercise.

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