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BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity (BETA)

Primary Purpose

Elderly, Parkinsons Disease, Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Gait and balance group training
Nordic walking (only osteoporosis group)
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elderly focused on measuring Balance, Gait, Physical activity

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Gait and balance group training

Gait and balance trainig + nordic walking

Control group

Arm Description

The balance-training program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in elderly and PD. For the PD group it has been modified based on the current knowledge of the neurophysiology and the inevitable constraints on mobility and postural control resulting from basal ganglia degeneration. The training will be conducted as a progressive individually adjusted group program, led by experienced physiotherapists and researchers in order to challenge the specific balance disorder of every participant and endorse progression. It is progressive and specific balance program including dual- and multitasks. The program is performed 3 times/week for 10-12 weeks.

(only for Osteoporosis group)

Outcomes

Primary Outcome Measures

Improved balance control
Improved gait
Improved physical activity
Reduced Fear of falling

Secondary Outcome Measures

Improved health related quality of life

Full Information

First Posted
August 15, 2011
Last Updated
October 13, 2020
Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT01417598
Brief Title
BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity
Acronym
BETA
Official Title
Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity- a Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Parkinsons Disease, Osteoporosis
Keywords
Balance, Gait, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gait and balance group training
Arm Type
Experimental
Arm Description
The balance-training program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in elderly and PD. For the PD group it has been modified based on the current knowledge of the neurophysiology and the inevitable constraints on mobility and postural control resulting from basal ganglia degeneration. The training will be conducted as a progressive individually adjusted group program, led by experienced physiotherapists and researchers in order to challenge the specific balance disorder of every participant and endorse progression. It is progressive and specific balance program including dual- and multitasks. The program is performed 3 times/week for 10-12 weeks.
Arm Title
Gait and balance trainig + nordic walking
Arm Type
Experimental
Arm Description
(only for Osteoporosis group)
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Gait and balance group training
Intervention Description
The balance-training program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in elderly and PD. For the PD group it has been modified based on the current knowledge of the neurophysiology and the inevitable constraints on mobility and postural control resulting from basal ganglia degeneration. The training will be conducted as a progressive individually adjusted group program, led by experienced physiotherapists and researchers in order to challenge the specific balance disorder of every participant and endorse progression. It is progressive and specific balance program including dual- and multitasks. The program is performed 3 times/week for 10-12 weeks.
Intervention Type
Other
Intervention Name(s)
Nordic walking (only osteoporosis group)
Intervention Description
To further test the hypothesis that physical activity may enhance the results from the balance training program pole striding will be added to the balance training program, at least 30-45 minutes three times per week during leisure time. Each individual in this group will be provided with individually adjusted poles, a pedometer and a diary to enter when and for how long time they have been walking.
Primary Outcome Measure Information:
Title
Improved balance control
Time Frame
Short-term
Title
Improved gait
Time Frame
Short-term
Title
Improved physical activity
Time Frame
Long-term
Title
Reduced Fear of falling
Time Frame
Short-term
Secondary Outcome Measure Information:
Title
Improved health related quality of life
Time Frame
Long-term

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
14183
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32985265
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.
Results Reference
derived
PubMed Identifier
30531385
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.
Results Reference
derived
PubMed Identifier
30407031
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.
Results Reference
derived
PubMed Identifier
28143463
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.
Results Reference
derived
PubMed Identifier
23017069
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.
Results Reference
derived

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BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity

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