Fidelity
Quality of delivery of the program core components
Training planning and report protocols from 110 group-training sessions were analysed, data from nine sessions (7% of total dose delivered) at one clinic were missing. Overall trainer fidelity to the core components of the group-training sessions was very high. In 104 out of 110 (94%), of the group training sessions, trainers designed exercises, which adhered to the 10-week HiBalance framework that outlines the specific balance sub-domains and dual-task components to be targeted, during which weeks. In the five sessions (4%) where fidelity was poor-fair, balance subdomains were trained, but exercises were not exactly in line with the 10-week HiBalance scheme. These five sessions all occurred at one clinic. We also analysed the nature of the exercise focus in Block C (weeks 7–10), where trainers were free to choose among the four balance components to target. In three of the four clinics, there was a tendency for trainers to continue to focus on two specific balance components in combination with motor or cognitive dual task, during the weeks 7 and 8. In the final two weeks of the program, all HiBalance subdomains were targeted within the same training sessions at all clinics.
Participant responsiveness to the core components
A majority (71%) of participants responded positively to the Overload component of the program – by responding that their balance was challenged to ‘partially’ or to ‘a high’ degree (See Table 2). Similarly, regarding perceptions of the Progressive nature of program difficulty, 88% of respondents reported that balance challenge had been progressed either partially/ to a high or very high degree. Program Specificity was explored in relation to perceived difficulty of exercises targeting the four specific balance sub-domains. Participants reported, for example, that exercises targeting Sensory integration as the most challenging and exercises targeting Anticipatory Postural adjustment as the least challenging of the four domains.
In terms of the HEP, approx. 50% of participants reported completing it, and a majority indicated that the program was adapted to their ability. A further 77% of participants indicated that they were motivated to continue with the HEP once the training ended.
Table 2
Participant responsiveness to core components of the HiBalance intervention
Participant perceptions | To a very small degree n (%) | To a Small degree n (%) | Partly n (%) | To a high degree n (%) | To a very high degree n (%) | Do not know n (%) |
Training overload My balance was challenged during group training | 3 (6) | 12 (23) | 35 (67) | 2 (4) | − | − |
Training progression The difficulty level increased during the training period | 1 (2) | 5 (10) | 25 (48) | 19 (37) | 2 (4) | − |
Training specificity i) Stability Limits Exercises involving trunk rotations and controlled leaning exercises challenged my balance | 3 (6) | 13 (27) | 17 (35) | 14 (29) | 1 (2) | 1 (2) |
ii) Anticipatory Postural Adjustments Exercises involving kicking and throwing a ball challenged my balance | 5 (10) | 12 (24) | 17 (35) | 12 (24) | 2 (4) | 1 (2) |
iii) Sensory Integration Exercises involving standing on soft and unstable surfaces challenged my balance | 1 (2) | 3 (6) | 16 (30) | 23 (43) | 10 (19) | − |
iv) Motor Agility Exercises involving walking over and around obstacles challenged my balance | 2 (4) | 9 (17) | 16 (30) | 21 (40) | 5 (9) | − |
Motor dual-task exercises To what extent did the added motoric task (e.g balancing items on a tray while walking) challenge your balance? | − | 2 (4) | 19 (36) | 26 (49) | 6 (11) | − |
Cognitive dual-task exercises To what extent did the added cognitive tasks (e.g.counting numbers) challenge your balance? | 2 (4) | 13 (25) | 22 (42) | 12 (23) | 4 (8) | − |
Recruitment
Recruitment of rehabilitation clinics
The research group selected eight clinics of varying nature and geographical location providing rehabilitation in the Stockholm region (Table 4). Clinics were approached firstly by mail, and subsequently by telephone if interest was expressed in the study. Six out of the eight clinics contacted agreed to join the study. Four clinics joined as ‘training clinics’ and provided the HiBalance intervention. Two clinics wished to join the project in the capacity of ‘control clinics’, whereby they did not provide the intervention but recruited and assessed control subjects from internal waiting lists. Clinics were included consecutively, with training commenced at clinics 1 and 2 during Spring 2016 and at clinics 3 and 4 during Autumn 2016.
Recruitment of study participants at the clinics
Each clinic was encouraged to recruit patients according to local routines. The recruitment process varied dependent on the clinics previous experience providing specialized neurological and/or PD outpatient group training (Table 3). Clinic four, a specialized neurological clinic with in- and out-patient rehabilitation, recruited independently to all groups through a process of internal referral. Clinic three on the other hand − a geriatric rehabilitation hospital with no previous experience of specialized out-patient PD group training − relied entirely on advertisement in local newspapers for recruitment. The research group assisted in this process. Clinics one and two, both with previous experience of PD-specific group training, initially intended to recruit from internal waiting lists, but were required to use advertisement when numbers were insufficient to fills groups. Inability of clinics one and two to recruit 12 participants respectively prior to study start resulted in insufficient numbers to enable randomization, resulting in a non-randomized study design. Higher staff turnover of trainers at clinic one & three resulted in fewer groups being trained at these sites, as time was required to recruit and educate new trainers. Recruitment rate of control participants at the two ‘control clinics’, was also lower than expected and four control participants initially included at these clinics were excluded prior to data analysis as they were Hoehn and Yahr stage 4, therefore not meet the study inclusion criteria. Due to this, clinic one was then required to assess a greater number of control participants than anticipated (n = 34).
Table 4
Description of participating clinics where training occurred
Clinic Description | Clinic 1 | Clinic 2 | Clinic 3 | Clinic 4 |
| University hospital Neurological department | Geriatric hospital Primary Care | Geriatric hospital Primary Care | Neurological rehabilitation Clinic |
Geographical location | North-central Inner-city | Inner-city Stockholm | West Stockholm | South Stockholm |
Individual outpatient rehab visits/ year | 834 | 14666 | 11617 | 3960 |
Number of unique patients /year | 394 | 2368 | 2140 | 263 |
Individual outpatient rehab visits for treatment of PD /year | 370 | 250 | 44 | 1071 |
Number of unique patients with PD /year | 75 | 53 | 42 | 63 |
Physical therapists Total/out-patient rehab | 7/1 | 12/9 | 12/5 | 12/2 |
Experience of PD-specific group training | Yes | Yes | No | No |
Experience of outpatient Neurological group training | Yes | Yes | No | Yes |
Training semesters | Spring 2016 | Spring 2016 | ─ | ─ |
─ | Autum 2016 | Autum 2016 | Autum 2016 |
Spring 2017 | Spring 2017 | Spring 2017 | Spring 2017 |
─ | Autum 2017 | ─ | Autum 2017 |
PT trainers | | | | |
Total during study period | 4 | 3 | 4 | 2 |
Participants included | | | | |
Total included training | 13 | 22 | 8 | 18 |
Total included controls1 | 34 | 7 | 9 | 0 |
Recruitment process | Internal process of referral & Advertisement | Internal process of referral & Advertisement | Advertisment only | Internal referral process |
PD: Parkinson’s disease. PT: Physical therapist. 1A further six control participants were included at two ‘control clinics’ not outlined in this table.
Reach
Parametric analysis of variance of the baseline characteristics of PwPD at the various clinics showed no significant differences between participants recruited in relation to; age (P = 0.165), years with the disease (P = 0.695), balance control (P = 0.648), gait speed (P = 0.688) or physical activity level (P = 0.132). The pattern was similar for the variance of non-parametric data; Functional mobility (chi-squared: 4.45, P = 0.216) and Executive function (chi-squared: 5.77, P = 0.122). Different recruitment processes did not therefore result in different samples of PwPD in relation to descriptive or disease-related characteristics. We deem that our target group of those with mild-moderate PD came into contact with the intervention at all training sites.
Response to the training program at different sites
No statistical difference was found in the proportion of those who improved their balance (beyond SEM of 2 points) across the different sites (P = 0.90). Similarly, no difference was observed in the proportions of those who improved their gait speed (beyond the SEM of 0.06 m/s) across the four training sites (P = 0.47).
Adverse events among the training group
A total of 12 falls occurred across the four training clinics, throughout all training blocks (A-C), with more falls occurring in block B where dual task exercises were introduced. It was most common for falls to have occurred while training anticipatory postural adjustment exercises involving ball play (40% of cases) as well as during motor agility exercises. Men were overrepresented (80% of cases) among adverse events occurring during the training sessions. Six people in the training group reported non-injurious falls or stumbles during the HEP.
Facilitators and barriers to program implementation
Seven out of ten of the CFIR sub-constructs explored in the interviews were represented in the data as influencing trainer perceptions of the program. Facilitators and barriers to program implementation could be categorized under the CFIR domains Intervention Characteristics, Outer Setting and Characteristics of Individuals. An overview of the analysis process involving coding, CFIR sub-constructs, category formation and grouping as barriers or facilitators to program delivery is shown in Table 5. There was no evidence in the transcripts that CFIR sub-constructs from Inner setting – Evidence strength and quality; Compatibility and Implementation climate – had positive or negative influences on trainer perceptions of program delivery.
Table 5
Overview of the qualitative analysis process of the investigation of the barriers and facilitators to program delivery
| Categories | Meaning unit | CFIR Sub-construct | Definition |
Facilitator | Disease and balance specific program | It’s nice that it (HiBalance) is targeted specifically at this diagnosis…and that it is specific balance training, there is already a lot of strength programs and mobility and so on | Relative advantage | Trainers perception of the advantage of implementing the intervention versus an alternative solution |
Facilitator | High frequency and intensity benefits those at mild disease stages | I have a feeling that those patients with Parkinson’s whose symptoms haven’t progessed so, that they have a hard time finding the right forum to ventilate their thoughts and ideas as well as really train. It often feels as if a lot of training that is out there is more targeted towards those where more pronounced balance problems | Patient needs and resources | The extent to which patient needs, as well as barriers and facilitators to meet those needs, are known and prioritized by the organization. |
Facilitator | Autonomy within a structure | I like that you have a skeleton structure in which you still have to make decisions in a lot of ways, dependent on the type of group you have. It’s nice to have a framework because it’s so easy to fall back on your usual favorite exercises | Adaptability | The degree to which an intervention can be adapted, tailored, refined, or reinvented to meet local needs. |
Facilitator | Certainty to teach the core elements increase with experience | The second time we held the program it was easier to convince patients of the importance of repeating simple exercises in the beginning | Self-efficacy | Trainers’ belief in their capabilities to execute courses of action to achieve implementation goals. |
Barrier | Maintaining specificity | During the first weeks it difficult to keep the exercises simple | Complexity | Perceived difficulty of implementation |
Barrier | Absence of fall-protective reactions | You should maybe not include a patient to this group if they don’t have any fall-protective reactions…it’s hard to test because there is a lot of trust involved in that assessment, but when you notice they are lacking I think you should advise against this program | Patients’ needs and resources | The extent to which patient needs, as well as barriers and facilitators to meet those needs, are known and prioritized by the organization. |
Barrier | Difficult to ascertain the initial level of balance challenge | I think it was difficult to understand which level were supposed to start at, that was tricky. Like how easy or difficult to set it, because we know that there should, where to start…. Add sth. about the pamphlets showing more advance exercises | Access to knowledge and information | Ease of access to digestible information and knowledge about the intervention and how to incorporate it into work tasks. |
Barrier | Heterogeneous patient groups in terms of balance | It is difficult when they (patients) are very uneven in what they can do. If one person needs to be followed and the others are clearly better, then you can’t really lift the difficulty level for the entire group | Knowledge and Beliefs about the intervention | Trainers attitudes toward and value placed on the intervention and principles related to the intervention |
Barrier | Low cognitive reserve restricts participation | We have had some people who were too cognitively impaired, and that becomes almost the biggest problem. It just is, they come late and they have difficulty following instructions… | Knowledge and Beliefs about the intervention Low cognitive reserve restricts participation | As above |
Barrier | Low cognitive reserve restricts participation | We have had some people who were too cognitively impaired, and that becomes almost the biggest problem. It just is, they come late and they have difficulty following instructions… | Knowledge and Beliefs about the intervention Low cognitive reserve restricts participation | As above |
Perceived facilitators of program implementation
The disease-specific nature of the program and it sole focus on balance was considered to fill an existing gap in terms of patients’ needs – disease and symptom-specific group training. Trainers expressed how existing forms of training tended to be more general in nature, and targeted a wider spectrum of neurological diagnoses, while also combining balance with cardiovascular or muscle strength training elements. Additionally, the specific and progressive focus on balance facilitated delivering a higher level of challenge, thus enabling those at mild levels of impairment to benefit from group training.
That it (HiBalance) is specifically targeted towards balance training, a lot of other training focuses on strength and mobility where maybe balance has been a smaller part…the specific focus on balance means that you can zone in one area and really train it hard.
Trainers described how a treatment frequency of twice a week over 10 weeks exceeded the more standard once weekly programs already in practice at their clinics. Program frequency was considered a facilitating factor for successful implementation as it enabled therapists to attain a more in-depth knowledge of each patient’s balance capacity, while also allowing patients to gain a better understanding of their capacity. Trainers also perceived it easier to expose all patients to a sufficiently high level of balance challenge or intensity – and therefore maintain program fidelity – when participants had mild as opposed to moderate levels of balance impairment.
Then it’s really positive to get to meet them (patients) so many times, because you really do get to know them, and because they also get the chance to get to know themselves, sometimes by doing extreme types of exercises
Trainers described the program as allowing for professional autonomy within the schematic structure, whereby exercises were not pre-set but needed to be constructed and progressed. They perceived this feature as something that encouraged creativity and ingenuity. The program structure was discussed as advantageous in two ways, firstly in providing a reassurance that all important elements would be targeted, and secondly, as the program does not consist of set exercises this allowed trainers the opportunity for professional autonomy. That exercises shifted in focus during alternate weeks was experienced as a facilitatory factor to effective delivery as it required trainers to ‘constantly re-think their approach’ to planning the training sessions.
Because it (HiBalance) is designed and so carefully thought through, it feels as if you can’t miss any important parts of balance…it’s easy otherwise if you can improvise completely freely that you can forget a certain part because you chose those exercises you like the best, it’s a reassuring feeling
Having completed one entire 10-week program gave trainers greater confidence in their ability to deliver the programs core components. This increased self-efficacy gave them greater certainty when stressing the importance of focusing on exercise quality as opposed to intensity during the initial two weeks. Trainers also described having gained perspective on the rate of progression of exercise challenge over time.
The difference was that we felt a little more, more confident about how we could handle everything. We knew how it would end, if you know what I mean, we know in which direction we were going. We didn’t know that the first time, but the build- up…we were much more sure about where we were heading. We felt like ─ now we are going to really drum this in, now we are going to stick to this ─
because we knew that soon it would get much more difficult.
Perceived barriers to program implementation
Trainers perceived cognitive impairment as a barrier for patients to benefit from the group sessions. They also discussed the limitations of standard physiotherapy assessment, which does not incorporate an objective assessment of cognition, when trying to establish a person’s suitability to group training. Trainers were mindful of the risk that people who performed poorly during cognitive dual-tasks could feel exposed or vulnerable in front of other group members. To offset this potential vulnerability, trainers proposed pairing patients of equal dual-task capacity.
I remember how when we did the cognitive exercises the first time, we realized how we really had to group two (patients) at a time who were around the same level, because otherwise there could be one person that really shined at the task, and one person that didn’t, you know… you didn’t want anyone to feel like they stood out in any way.
For similar reasons, heterogeneous patient groups in terms of balance capacity were considered a barrier to maintaining fidelity to program core components. If one person’s capacity differed largely from others, due to either low or high levels of balance impairment, this was considered a hinder to achieving a sufficiently high level of challenge for all members of the group.
If someone stands out too much, because they are either too good or too bad, well then it gets very difficult to challenge them, if they have poor balance then you need to point mark them and then you lose a certain flow
In accordance with this, trainers perceived that homogeneity in relation to balance capacity facilitated a better group dynamic among participants. An additional barrier that emerged during interview analysis regarded patients with impaired balance reactions. Trainers suggested that, in the interest of patient safety when performing highly challenging exercises, people with a total absence of balance reactions should be not be included in this program.
Trainers’ difficulties in choosing a suitable initial level of exercise challenge was a recurring theme, as were difficulties determining an adequate weekly rate of exercise progression. This was especially the case when choosing cognitive dual-task exercises where it was difficult to choose an exercise that challenged patients at an individual and even more so at group level.
I thought that it has been hard to understand which level to start at, that was really tricky. Like just how easy or difficult it was supposed to be in the beginning, because you knew that you were supposed to step up the challenge gradually.
The initial two weeks of the program were perceived as somewhat repetitive and trainers felt a need to advance the exercises more than the program structure indicated. They were conscious to avoid patients feeling bored or unmotivated with the program in the early stages. This perceived difficulty was grounded in difficulties maintaining specificity when choosing exercises that targeted one particular balance sub-component during Block A. It was perceived as easier to construct complex exercises targeting several domains than to streamline tasks to target one specific balance component at a time. Trainers commonly perceived that maintaining fidelity to exercise specificity during Blocks A and B a greater challenge, than when all components could be targeted simultaneously in the final block of the program.
We felt as if the first couple of weeks were too easy and that we felt to steered in the different areas, sometimes we would have like to progress the exercises at a faster rate… and then it’s also the case that the patients want to push forward as well, they want to constantly increase the difficulty level, perhaps they thought it was too easy in the beginning
Trainer suggestions for program adaptation
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Adding lack of protective fall reflexes (0/6 points on the Balance Reaction sub-component of the miniBESTest) as an exclusion criteria to the program.
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Reducing the initial two-week block to one week in order to start challenging participants earlier on in the program.
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Adding basic balance exercises to the HEP and plan a third session during week one to allow for instruction and individual adaptation of the HEP.
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Set individual goals with patients during inclusion to the groups in order to mirror clinical practice.
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Running parallel training groups for patients at mild and moderate levels of impairment, could benefit maintain fidelity to the highly challenging aspect of the program.
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The use of exercise ‘stations’ when the gym space is small, so that patients of similar balance capacity can be paired. That way high levels of challenge can be achieved and safety ensured by supervising at a particular station rather than one particular person.