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

NCT ID: NCT01417598

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elderly Parkinsons Disease Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Gait and balance group training

Intervention Type OTHER

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

(only for Osteoporosis group)

Group Type EXPERIMENTAL

Nordic walking (only osteoporosis group)

Intervention Type OTHER

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* moderate-severe dementia (Mini-Mental score \<24)
* respiratory, cardiovascular, musculoskeletal or neurological (except PD) disorders that may interfere with participation in the exercise program
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alexandra Halvarsson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karolinska Institutet

Stockholm, Huddinge, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32985265 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30531385 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30407031 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28143463 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23017069 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K2011-69P-20908-02-4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Restoring Skill in Walking
NCT00177359 COMPLETED PHASE2