An interventional study of HiBalance training program in Parkinson Disease, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
This effectiveness-implementation study is a part of the larger study BETA-PD (Balance, Elderly, Training and Activity in Parkinson's Disease), which has the long-term goal to reduce the risk of falling in people with Parkinson's disease (PD) by improving balance, gait and physical activity level. The main hypothesis is that highly challenging balance training will lead to greater gait and balance ability, increased levels of physical activity and an improved health related quality of life. The main aims of the study are to evaluate the effectiveness of the HiBalance program in real-life clinical settings, while exploring facilitators and barriers for program implementation on a wider scale.
The clinical features of PD include progressive postural instability, hypokinesia, tremor and rigidity. It is therefore common that people with PD experience reduced balance and gait function, symptoms which can have far-reaching negative effects on their health and quality of life. Injurious falls and fear of falling are especially prevalent among those with PD, a factor which may partly explain why this group are less physically active than older people of a similar age without the diagnosis. Balance and gait training, on the other hand, have been shown effective in PD and also appear to have potential neuro-protective properties. Research in the area of balance training in PD disease however is sparse and previous interventions have been criticized for applying training stimuli which lacked intensity and challenge.
The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The program was developed to affect symptom-specific balance impairments in PD by targeting four main subsystems underlying balance control (stability limits, anticipatory postural adjustments, sensory integration and motor agility). The intervention consists of a 10-week progressive balance training program in group format (5-7 participants). Each training session is conducted by a minimum of 2 physiotherapist trainers, during twice weekly 1-hour sessions (20 hours in total). Additionally, a home-exercise program is carried out by the participants once a week during the trial period. The difficulty level of the group-based training is increased in three consecutive blocks. To ensure highly challenging exercises, each task is individually adjusted by altering the area of base of support, increasing movement speed/amplitude and/or restricting vision and varying the grade of multitasking. The program has previously been proven feasible [Conradsson, 2012] and effective [Conradsson, 2015] in improving balance and gait impairments in a randomized controlled hospital setting. In addition, favorable transfer effects were seen in relation to physical activity levels and the performance of activities of everyday life.
For research interventions to be adopted in real-life clinical settings however a level of adaptation is required. Best practice then involves evaluating the effectiveness of efficacious programs in clinical settings, in order to verify whether or not the adaptation has attenuated the effective core elements of the program itself.
The current study combines a clinical effectiveness trial together with implementation research. Use of a type-1 hybrid design will allow the effects of the HiBalance program in clinical settings to be tested while simultaneously gathering information on barriers and facilitators to the implementation process [Curran, 2012]. Use of the hybrid design also allows for constant monitoring of the process by which the intervention is applied, and therefore allow problems in early application to be identified and quickly altered so as to ensure better outcomes. A participatory approach will be adhered to whereby 'users' of the program (physiotherapist trainers) will be actively involved in all stages of the program adaptation, process and outcome evaluation. This approach is recommended in order to increase the relevance, acceptability and successful implementation of the program. The Consolidated Framework for Implementation Research (CFIR) will be used in the current study to guide the investigation of potential barriers to and facilitators of the implementation process [Damschroder, 2009 ].
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 117 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program.
Other: HiBalance training program
Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.
Change in Mini-BESTest Score From Baseline at 1 Week Post Intervention.
Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. Maximum points 28. 0-28 points with higher scores indicating better balance control The mini-BESTest is an assessment of balance performance and will be performed by the physiotherapists in the respective clinics.
Time frame: Change in Mini-BESTest score from baseline at 1 week post intervention.
Change in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention.
The 10-meter walking test assesses gait performance was performed by the physiotherapists in the respective clinics. Gait speed was measured as m/sec during 10 meters
Time frame: From baseline at 1 week post intervention.
Change in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.
The TUG test assesses functional mobility and will be performed by the physiotherapists in the respective clinics. TUG test measures performance of a sequential locomotor task (rising from a chair, walking 3 m, turning and walking back to the chair). Timed Up and Go (TUG) test is measured in seconds it takes to perform the task.
Time frame: From baseline at 1 week post intervention.
Change in EQ-5D Score From Baseline at 1week Post Intervention.
The EQ-5D is a 2-paged form assessing health-related quality of life and will be filled in by participants. European Quality of Life- 5 dimensions (EQ-5D), The visual analogue scale (VAS) indicates the general health status ranging from 0-100 with 100 indicating the best health status
Time frame: From baseline at 1week post intervention.
Change in Activities-specific Balance Confidence (ABC) Scale
The ABC scale assesses self-reported balance confidence and will be filled in by study participants. It consists of 16 items that are rated from from 0-100% where 0% indicates no confidence and 100% complete confidence. The overall score is calculated by adding the item scores and dividing the total by 16 (i.e. the number of items). This total score ranges from 0% to 100%.
Time frame: From baseline at 1 week post intervention.
Change in Physical Activity Level From Baseline 1 Week Post Intervention.
Participants will wear accelerometers for a 7-day period directly before and after the intervention. Physical activity level (steps per day)
Time frame: from baseline to 1 week post intervention
Change in Dual Task Interference During the Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.
The TUG test assesses functional mobility and will be performed by the physiotherapists in the respective clinics. TUG test measures performance of a sequential locomotor task (rising from a chair, walking 3 m, turning and walking back to the chair).The TUG COG test involves performance of the TUG test while sequentially subtracting the number 3 from a start number. The time difference between the TUG and the TUG COG reflects dual-task interference during functional mobility and is calculated be expressed as a percentage: (TUG COG - TUG)/TUG.
Time frame: From baseline at 1 week post intervention.
| Milestone | Balance Training Group | Control Group |
|---|---|---|
| Started | 61 | 56 |
| Completed | 53 | 46 |
| Not completed | 8 | 10 |
| Withdrew: Withdrawal by subject | 8 | 10 |
Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. Maximum points 28. 0-28 points with higher scores indicating better balance control The mini-BESTest is an assessment of balance performance and will be performed by the physiotherapists in the respective clinics.
| score on a scale | Balance Training Group | Control Group |
|---|---|---|
| Change in Mini-BESTest Score From Baseline at 1 Week Post Intervention. | 2.0 ± 2.0 | -0.2 ± 2.4 |
The 10-meter walking test assesses gait performance was performed by the physiotherapists in the respective clinics. Gait speed was measured as m/sec during 10 meters
| m/sec | Balance Training Group | Control Group |
|---|---|---|
| Change in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention. | 0.2 ± 0.41 | -0.04 ± 0.14 |
The TUG test assesses functional mobility and will be performed by the physiotherapists in the respective clinics. TUG test measures performance of a sequential locomotor task (rising from a chair, walking 3 m, turning and walking back to the chair). Timed Up and Go (TUG) test is measured in seconds it takes to perform the task.
| seconds | Balance Training Group | Control Group |
|---|---|---|
| Change in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention. | -0.4 (-1.13 to 0.5) | 0 (-1.6 to 1.2) |
The EQ-5D is a 2-paged form assessing health-related quality of life and will be filled in by participants. European Quality of Life- 5 dimensions (EQ-5D), The visual analogue scale (VAS) indicates the general health status ranging from 0-100 with 100 indicating the best health status
| units on a scale | Balance Training Group | Control Group |
|---|---|---|
| Change in EQ-5D Score From Baseline at 1week Post Intervention. | 5.5 (-5 to 15) | 0 (-10 to 5) |
The ABC scale assesses self-reported balance confidence and will be filled in by study participants. It consists of 16 items that are rated from from 0-100% where 0% indicates no confidence and 100% complete confidence. The overall score is calculated by adding the item scores and dividing the total by 16 (i.e. the number of items). This total score ranges from 0% to 100%.
| units on a scale | Balance Training Group | Control Group |
|---|---|---|
| Change in Activities-specific Balance Confidence (ABC) Scale | 68 ± 16.9 | 70 ± 18.2 |
Participants will wear accelerometers for a 7-day period directly before and after the intervention. Physical activity level (steps per day)
| steps per day | Balance Training Group | Control Group |
|---|---|---|
| Change in Physical Activity Level From Baseline 1 Week Post Intervention. | -288 ± 1428 | -390 ± 2016 |
The TUG test assesses functional mobility and will be performed by the physiotherapists in the respective clinics. TUG test measures performance of a sequential locomotor task (rising from a chair, walking 3 m, turning and walking back to the chair).The TUG COG test involves performance of the TUG test while sequentially subtracting the number 3 from a start number. The time difference between the TUG and the TUG COG reflects dual-task interference during functional mobility and is calculated be expressed as a percentage: (TUG COG - TUG)/TUG.
| percentage of interference | Balance Training Group | Control Group |
|---|---|---|
| Change in Dual Task Interference During the Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention. | -1.22 (-6.2 to 0.66) | 1.05 (-3.07 to 3.51) |
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Balance Training Group | 0/61 (0%) | 0/61 (0%) | 12/61 (19.7%) |
| Control Group | — | — | — |
| Event | Balance Training Group | Control Group |
|---|---|---|
| FallsInjury, poisoning and procedural complications | 12/61 | — |
| Age, Continuous(years) | Balance Training Group | Control Group | Total |
|---|---|---|---|
| Mean | 70 ± 8.5 | 70 ± 6.5 | 70. ± 7.6 |
| Sex: Female, Male(Participants) | Balance Training Group | Control Group | Total |
|---|---|---|---|
| Female | 33 | 22 | 55 |
| Male | 28 | 34 | 62 |
| Race (NIH/OMB)(Participants) | Balance Training Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 61 | 56 | 117 |
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