Trial record 9 of 59 for:    "balance impairment" OR "balance training" | Open Studies

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

This study is currently recruiting participants.
Verified August 2011 by Karolinska Institutet
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01417598
First received: August 15, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

Balance control, physical activity and health related quality of life will be assessed before and after a 12 weeks training program as well as 6, 12 and 24 months thereafter in 150 elderly (>65) with balance problems (75 with osteoporosis, 75 with Parkinson's disease). Subjects will be assigned to 3 groups: balance training, balance training and Nordic walking, or control group. The training will be progressive and specific to functional balance tasks, performed on 5 levels, and incorporates 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. The addition of regular walking will further improve the physical activity level and health related quality of life. 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.


Condition Intervention
Elderly
Parkinsons Disease
Osteoporosis
Other: Gait and balance group training
Other: Nordic walking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity- a Randomized Controlled Study.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Improved health related quality of life [ Time Frame: 3, 9, 15 months after the intervention starts ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gait and balance group training
It is progressive and specific to functional balance tasks, i.e. it includes elements that represent activities included in and required for independent activities of daily living (i.e. sitting, standing, reaching and walking). Strength and flexibility components are integrated into the program to decrease the need for separate programs for these abilities. The program is performed on five different levels where each level reflects different demands on the postural control system. Each participant will receive exercises that are individually challenging, which is crucial for progress. 2-3 times/week for 12 weeks
Other: Gait and balance group training
It is progressive and specific to functional balance tasks, i.e. it includes elements that represent activities included in and required for independent activities of daily living (i.e. sitting, standing, reaching and walking). Strength and flexibility components are integrated into the program to decrease the need for separate programs for these abilities. The program is performed on five different levels where each level reflects different demands on the postural control system. Each participant will receive exercises that are individually challenging, which is crucial for progress.
Experimental: Gait and balance trainig + nordic walking Other: Nordic walking
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.
No Intervention: Control group

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 1-3), > 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, and have experienced at least one fall in the last 12 months.

Exclusion criteria's for all subjects are:

  • frequent fall related fractures during the last year
  • focal muscle weakness
  • paralysis
  • neuropathies
  • moderate-severe dementia (Mini-Mental score <24)
  • serious visual impairment
  • symptomatic orthostatic hypotension
  • respiratory, cardiovascular or musculoskeletal disorders that may interfere with participation in the exercise program
  • diagnosed severe cancer and use of medication that severely impairs balance or strength
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417598

Contacts
Contact: Agneta E Ståhle, Assoc. prof +46852488810 agneta.stahle@ki.se
Contact: Erika Franzén, Ass. Prof +46852488878 erika.franzen@ki.se

Locations
Sweden
Karolinska Institutet Recruiting
Stockholm, Huddinge, Sweden, 14183
Contact: Agneta E Ståhle, assoc. prof     +46852488810     agneta.stahle@ki.se    
Contact: Erika Franzén, Ass prof     +46852488878     erika.franzen@ki.se    
Principal Investigator: Agneta E Ståhle, Assoc. prof            
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agneta Ståhle, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01417598     History of Changes
Other Study ID Numbers: K2011-69P-20908-02-4
Study First Received: August 15, 2011
Last Updated: August 15, 2011
Health Authority: Sweden: Regional etichal review board-Stockholm

Keywords provided by Karolinska Institutet:
Balance
Gait
Physical activity

Additional relevant MeSH terms:
Osteoporosis
Parkinson Disease
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013