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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Agneta Stahle, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01417598
First received: August 15, 2011
Last updated: October 28, 2013
Last verified: October 2013

August 15, 2011
October 28, 2013
January 2010
June 2014   (final data collection date for primary outcome measure)
  • Improved balance control [ Time Frame: Short-term ] [ Designated as safety issue: No ]
  • Improved gait [ Time Frame: Short-term ] [ Designated as safety issue: No ]
  • Improved physical activity [ Time Frame: Long-term ] [ Designated as safety issue: No ]
  • Reduced Fear of falling [ Time Frame: Short-term ] [ Designated as safety issue: No ]
  • Improved balance control [ Time Frame: 3, 9 and 15 months after the intervention starts ] [ Designated as safety issue: No ]
  • Improved gait [ Time Frame: 3, 9, 15 months after the intervention starts ] [ Designated as safety issue: No ]
  • Improved physical activity [ Time Frame: 3, 9, 15 months after the intervention starts ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01417598 on ClinicalTrials.gov Archive Site
Improved health related quality of life [ Time Frame: Long-term ] [ Designated as safety issue: No ]
Improved health related quality of life [ Time Frame: 3, 9, 15 months after the intervention starts ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity
Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity- a Randomized Controlled Study.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Elderly
  • Parkinsons Disease
  • Osteoporosis
  • Other: Gait and balance group training
    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.
  • Other: Nordic walking (only osteoporosis group)
    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.
  • Experimental: Gait and balance group training
    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: Other: Gait and balance group training
  • Experimental: Gait and balance trainig + nordic walking
    (only for Osteoporosis group)
    Intervention: Other: Nordic walking (only osteoporosis group)
  • No Intervention: Control group
Conradsson D, Löfgren N, Ståhle A, Hagströmer M, Franzén 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2014
June 2014   (final data collection date for primary outcome measure)
  • 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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01417598
K2011-69P-20908-02-4
No
Agneta Stahle, Karolinska Institutet
Karolinska Institutet
The Swedish Research Council
Not Provided
Karolinska Institutet
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP