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

Not Applicable

• Conditions: Parkinsons Disease; Osteoporosis; Elderly
• Interventions: Other: Gait and balance group training; Other: Nordic walking (only osteoporosis group)

• Registration Number: NCT01417598
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Primary Completion: 2016-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gait and balance group training	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.
Gait and balance trainig + nordic walking	Nordic walking (only osteoporosis group)	(only for Osteoporosis group)

Primary Outcome Measures

Name	Time	Method
Improved physical activity	Long-term
Improved gait	Short-term
Reduced Fear of falling	Short-term
Improved balance control	Short-term

Secondary Outcome Measures

Name	Time	Method
Improved health related quality of life	Long-term

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Huddinge, Sweden