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

Osteoporosis Clinical Trial

— BETA  

Official title:

Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity- a Randomized Controlled Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01417598
• Other study ID #: K2011-69P-20908-02-4
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Elderly
• Osteoporosis
• Parkinson Disease
• Parkinsons Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Huddinge

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved balance control		Short-term
Primary	Improved gait		Short-term
Primary	Improved physical activity		Long-term
Primary	Reduced Fear of falling		Short-term
Secondary	Improved health related quality of life		Long-term