Clinical trial NCT02727478: Effectiveness and Implementation of the HiBalance Program in Clinical Practice
Official title: Highly Challenging Balance Training for People With Parkinson's Disease (the BETA-PD Study): Non-randomized Hybrid Effectiveness-implementation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Balance
Rehabilitation
Exercise
basal ganglia
Gait
Training
physical activity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2016-04-04
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[Damschroder, 2009 \].

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mini-BESTest Score From Baseline at 1 Week Post Intervention.
timeFrame: Change in Mini-BESTest score from baseline at 1 week post intervention.
Secondary outcomes:
measure: Change in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention.
timeFrame: From baseline at 1 week post intervention.
measure: Change in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.
timeFrame: From baseline at 1 week post intervention.
measure: Change in EQ-5D Score From Baseline at 1week Post Intervention.
timeFrame: From baseline at 1week post intervention.
measure: Change in Activities-specific Balance Confidence (ABC) Scale
timeFrame: From baseline at 1 week post intervention.
measure: Change in Physical Activity Level From Baseline 1 Week Post Intervention.
timeFrame: from baseline to 1 week post intervention
measure: Change in Dual Task Interference During the Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.
timeFrame: From baseline at 1 week post intervention.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet
state: Södermanland
Study officials:
affiliation: Karolinska Institutet
name: Erika Franzén, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conradsson D, Lofgren N, Stahle A, Hagstromer M, Franzen E. A novel conceptual framework for balance training in Parkinson's disease-study protocol for a randomised controlled trial. BMC Neurol. 2012 Sep 27;12:111. doi: 10.1186/1471-2377-12-111.
citation: Conradsson D, Lofgren N, Nero H, Hagstromer M, Stahle A, Lokk J, Franzen E. The Effects of Highly Challenging Balance Training in Elderly With Parkinson's Disease: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Oct;29(9):827-36. doi: 10.1177/1545968314567150. Epub 2015 Jan 21.
citation: Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
citation: Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
citation: Leavy B, Joseph C, Lofgren N, Johansson H, Hagstromer M, Franzen E. Outcome Evaluation of Highly Challenging Balance Training for People With Parkinson Disease: A Multicenter Effectiveness-Implementation Study. J Neurol Phys Ther. 2020 Jan;44(1):15-22. doi: 10.1097/NPT.0000000000000298.
citation: Leavy B, Joseph C, Kwak L, Franzen E. Implementation of highly challenging balance training for Parkinson's disease in clinical practice: a process evaluation. BMC Geriatr. 2021 Feb 1;21(1):96. doi: 10.1186/s12877-021-02031-1.
citation: Leavy B, Kwak L, Hagstromer M, Franzen E. Evaluation and implementation of highly challenging balance training in clinical practice for people with Parkinson's disease: protocol for the HiBalance effectiveness-implementation trial. BMC Neurol. 2017 Feb 7;17(1):27. doi: 10.1186/s12883-017-0809-2.