Clinical trial NCT01417598: BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity
Official title: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity- a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly
Parkinsons Disease
Osteoporosis
Keywords: Balance
Gait
Physical activity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2011-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Balance control, physical activity and health related quality of life will be assessed before and after a 10 to 12 weeks training program as well as 6 and 12 months thereafter in 200 elderly (\>60) with balance problems (100 with osteoporosis, 100 with Parkinson's disease). Osteoporosis subjects will be assigned to 3 groups (balance training, balance training and Nordic walking, or control group) and Parkinson's subjects to 2 groups (balance training or a control group). The training will be progressive and specific incorporating dual task exercises (directly related to an increased risk of falling). Clinical and laboratory gait and balance measures as well as questionnaires will be used to assess physical function and quality of life. An earlier study, investigating this training program in healthy elderly with balance problems showed that the training was well-tolerated and effective, with a significant increase in balance control, physical function and activity. In this study, we expect that an improvement in balance function, physical activity and health related quality of life, which will lead to a decreased number of falls, prevent and/or postpone incidence of a hazardous fall and thereby reduce the burden on the health care system. Our model for functional balance training and outcome methods will expand techniques and tools available to physical therapists and health care scientist treating and evaluating patients with loss of balance function. Elderly receiving therapy with the goal to improve or recuperate physical function and balance will benefit from this project.


Eligibility criteria: * Osteoporosis: To be included the candidate must: be \>65 years with osteoporosis objectively verified by Dual energy X-ray absorptiometry (DXA) in the hip and lumbar back,be an independent ambulator, have experienced at least one fall in the last 12 months and have an adequate medical treatment for their osteoporosis.
* Parkinson's disease: All PD subjects will have a clinical diagnosis of -idiopathic‖ PD (Hoehn \&Yahr scores 2-3), \> 60 years of age and no other existing neuromuscular disorders, including severely flexed posture. In addition, the subjects will have no history suggesting -atypical‖ PD symptoms.

Exclusion criteria's for all subjects are:

* moderate-severe dementia (Mini-Mental score \<24)
* respiratory, cardiovascular, musculoskeletal or neurological (except PD) disorders that may interfere with participation in the exercise program

Primary outcomes:
measure: Improved balance control
timeFrame: Short-term
measure: Improved gait
timeFrame: Short-term
measure: Improved physical activity
timeFrame: Long-term
measure: Reduced Fear of falling
timeFrame: Short-term
Secondary outcomes:
measure: Improved health related quality of life
timeFrame: Long-term
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Huddinge
Study officials:
References:
citation: Rennie L, Opheim A, Dietrichs E, Lofgren N, Franzen E. Highly challenging balance and gait training for individuals with Parkinson's disease improves pace, rhythm and variability domains of gait - A secondary analysis from a randomized controlled trial. Clin Rehabil. 2021 Feb;35(2):200-212. doi: 10.1177/0269215520956503. Epub 2020 Sep 28.
citation: Lofgren N, Conradsson D, Joseph C, Leavy B, Hagstromer M, Franzen E. Factors Associated With Responsiveness to Gait and Balance Training in People With Parkinson Disease. J Neurol Phys Ther. 2019 Jan;43(1):42-49. doi: 10.1097/NPT.0000000000000246.
citation: Lofgren N, Conradsson D, Rennie L, Moe-Nilssen R, Franzen E. The effects of integrated single- and dual-task training on automaticity and attention allocation in Parkinson's disease: A secondary analysis from a randomized trial. Neuropsychology. 2019 Feb;33(2):147-156. doi: 10.1037/neu0000496. Epub 2018 Nov 8.
citation: Conradsson D, Nero H, Lofgren N, Hagstromer M, Franzen E. Monitoring training activity during gait-related balance exercise in individuals with Parkinson's disease: a proof-of-concept-study. BMC Neurol. 2017 Jan 31;17(1):19. doi: 10.1186/s12883-017-0804-7.
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.