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Effectiveness and Implementation of the HiBalance Program in Clinical Practice

Highly Challenging Balance Training for People With Parkinson's Disease (the BETA-PD Study): Non-randomized Hybrid Effectiveness-implementation Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02727478
Acronym
BETA-PD
Enrollment
117
Registered
2016-04-04
Start date
2016-03-28
Completion date
2018-09-28
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Balance, Rehabilitation, Exercise, basal ganglia, Gait, Training, physical activity

Brief summary

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.

Detailed description

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 \[Damschroder, 2009 \].

Interventions

OTHERHiBalance training program

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.

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosed idiopathic Parkinson's Disease * Measured balance impairment (according to the mini-BESTest) * Hoehn and Yahr stages 2-3 * Independent ambulator indoors without a walking aid

Exclusion criteria

* Cognitive impairment which hinders participation in group training * The presence of comorbidities which hinder safe participation in group training

Design outcomes

Primary

MeasureTime frameDescription
Change in Mini-BESTest Score From Baseline at 1 Week Post Intervention.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.

Secondary

MeasureTime frameDescription
Change in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.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.
Change in EQ-5D Score From Baseline at 1week Post Intervention.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
Change in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention.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
Change in Physical Activity Level From Baseline 1 Week Post Intervention.from baseline to 1 week post interventionParticipants will wear accelerometers for a 7-day period directly before and after the intervention. Physical activity level (steps per day)
Change in Dual Task Interference During the Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.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.
Change in Activities-specific Balance Confidence (ABC) ScaleFrom baseline at 1 week post intervention.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%.

Countries

Sweden

Participant flow

Participants by arm

ArmCount
Balance Training Group
1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: 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.
61
Control Group
Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
56
Total117

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject810

Baseline characteristics

CharacteristicControl GroupTotalBalance Training Group
Age, Continuous70 years
STANDARD_DEVIATION 6.5
70. years
STANDARD_DEVIATION 7.6
70 years
STANDARD_DEVIATION 8.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
56 Participants117 Participants61 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
22 Participants55 Participants33 Participants
Sex: Female, Male
Male
34 Participants62 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 610 / 0
other
Total, other adverse events
12 / 610 / 0
serious
Total, serious adverse events
0 / 610 / 0

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
Balance Training GroupChange in Mini-BESTest Score From Baseline at 1 Week Post Intervention.2.0 score on a scaleStandard Deviation 2
Control GroupChange in Mini-BESTest Score From Baseline at 1 Week Post Intervention.-0.2 score on a scaleStandard Deviation 2.4
p-value: <0.001ANOVA
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Balance Training GroupChange in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention.0.2 m/secStandard Deviation 0.41
Control GroupChange in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention.-0.04 m/secStandard Deviation 0.14
p-value: =0.001ANOVA
Secondary

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.

ArmMeasureValue (MEDIAN)Dispersion
Balance Training GroupChange in Activities-specific Balance Confidence (ABC) Scale68 units on a scaleStandard Deviation 16.9
Control GroupChange in Activities-specific Balance Confidence (ABC) Scale70 units on a scaleStandard Deviation 18.2
p-value: =0.301ANOVA
Secondary

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.

ArmMeasureValue (MEDIAN)
Balance Training GroupChange in Dual Task Interference During the Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.-1.22 percentage of interference
Control GroupChange in Dual Task Interference During the Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.1.05 percentage of interference
p-value: 0.039Wilcoxon (Mann-Whitney)
Secondary

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.

ArmMeasureValue (MEDIAN)
Balance Training GroupChange in EQ-5D Score From Baseline at 1week Post Intervention.5.5 units on a scale
Control GroupChange in EQ-5D Score From Baseline at 1week Post Intervention.0 units on a scale
p-value: =0.065Wilcoxon (Mann-Whitney)
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Balance Training GroupChange in Physical Activity Level From Baseline 1 Week Post Intervention.-288 steps per dayStandard Deviation 1428
Control GroupChange in Physical Activity Level From Baseline 1 Week Post Intervention.-390 steps per dayStandard Deviation 2016
p-value: =0.792ANOVA
Secondary

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.

ArmMeasureValue (MEDIAN)
Balance Training GroupChange in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.-0.4 seconds
Control GroupChange in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.0 seconds
p-value: 0.254Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026