ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 12 for:    19664226 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Effectiveness and Implementation of the HiBalance Program in Clinical Practice (BETA-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02727478
Recruitment Status : Active, not recruiting
First Posted : April 4, 2016
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Erika Franzén, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: HiBalance training program Not Applicable

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 ].


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Highly Challenging Balance Training for People With Parkinson's Disease (the BETA-PD Study): Non-randomized Hybrid Effectiveness-implementation Trial
Study Start Date : March 2016
Actual Primary Completion Date : February 20, 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Balance training group
1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program.
Other: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Mini-BESTest [ Time Frame: Measurement 1:1-2 weeks prior to the intervention, Measurement 2: Change in Mini-BESTest score from baseline at 1 week post intervention. ]
    The mini-BESTest is an assessment of balance performance and will be performed by the physiotherapists in the respective clinics.


Secondary Outcome Measures :
  1. 10-meter walking test [ Time Frame: Measurement 1:1-2 weeks prior to the intervention, Measurement 2: Change in 10-meter walking test score from baseline at 1 week post intervention. ]
    The 10-meter walking test assesses gait performance and will be performed by the physiotherapists in the respective clinics.

  2. Timed Up and Go (TUG) test - with and without cognitive and motor tasks [ Time Frame: Measurement 1:1-2 weeks prior to the intervention, Measurement 2: Change in 10-meter walking 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.

  3. Physical activity level and intensity [ Time Frame: Measurement : One week prior to intervention, Measurement 2: 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.

  4. European Quality of Life- 5 dimensions (EQ-5D) [ Time Frame: Measurement 1:1-2 weeks prior to the intervention, Measurement 2: 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.

  5. The Activities-specific Balance Confidence (ABC) Scale [ Time Frame: Measurement 1:1-2 weeks prior to the intervention, Measurement 2: Change in ABC score from baseline at 1 week post intervention. ]
    The ABC scale assesses self-reported balance confidence and will be filled in by study participants.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727478


Locations
Sweden
Karolinska institutet
Stockholm, Södermanland, Sweden, 14183
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
Principal Investigator: Erika Franzén, PhD Karolinska Institutet

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erika Franzén, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02727478     History of Changes
Other Study ID Numbers: 2016/210-31/2
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Erika Franzén, Karolinska Institutet:
Balance
Rehabilitation
Exercise
basal ganglia
Gait
Training
physical activity

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases