Parkinson DiseaseNCT07859566
Home-Based Exercise Program After Community Balance Training for Parkinson's Disease
A study testing Home-based exercise program with remote checking and coaching and General wellness guidance in people with Parkinson Disease and Accidental Falls, run by Oklahoma State University at 4 sites in United States.
Trial summary
This study tested whether a home-based exercise program helps older adults with Parkinson's disease keep the improvements they gain from a community balance program. Participants lived in small towns and rural communities in Oklahoma, where access to movement disorder specialists is limited. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Parkinson Disease, Accidental Falls, Postural Balance
- What is being tested?
- Home-based exercise program with remote checking and coaching and General wellness guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Dec 2025to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Parkinson's disease
- Aged 60 years or older
- Resides in a rural or small-town community in Oklahoma
- Able to participate in a community-based group exercise program
- Willing and able to provide informed consent
Who cannot join
- Medical condition that prevents safe participation in balance exercise
- Unable to attend the community-based sessions
Trial locations and contacts
4 sites in 1 country.
United States4 sites
First Presbyterian Church
Stillwater, Oklahoma, 74075
Legacy Village of Stillwater
Stillwater, Oklahoma, 74075
LIFE Center - Adult Day Services
Stillwater, Oklahoma, 74075
The Center For Individuals with Physical Challenges
Tulsa, Oklahoma, 74104
About this study
Official title: Advanced Recreational Therapy Balance and Fall-Prevention Program for Individuals With Parkinson's Disease in Small Cities
This study tested whether a home-based exercise program helps older adults with Parkinson's disease keep the improvements they gain from a community balance program.
Participants lived in small towns and rural communities in Oklahoma, where access to movement disorder specialists is limited. All participants first took part in a three-month community-based recreational therapy balance program. At the end of those three months, participants were randomly assigned to one of two groups. One group continued with a home-based program for twelve weeks, which included an exercise manual, instructional videos, and a weekly telephone call from a researcher. The other group received general wellness guidance without follow-up contact.
Read more
Participants were assessed three times: before the community program began, at three months, and at six months. The assessments measured walking speed, stride length, and cadence; postural stability; concern about falling; anxiety and depression; social connectedness; and quality of life.
The purpose of the study was to learn whether continued support at home helps people hold onto the gains they make in a community program, and how quickly those gains are lost without that support.
Read the detailed description
Parkinson's disease is a progressive neurodegenerative disorder. In rural regions, where access to movement disorder specialists is limited, individuals with Parkinson's disease face increased risks of mobility decline, falls, and social isolation. In Oklahoma, 34% of the population lives in rural areas. Although physical activity improves mobility, reduces fall risk, and enhances quality of life, fewer than 30% of individuals with Parkinson's disease exercise regularly. Rural patients face barriers including limited transportation, fear of injury, and a lack of local programs or peer support.
Preliminary pilot work showed short-term gains in gait velocity and balance following supervised training, but these improvements regressed during follow-up without continued support. This study evaluated a hybrid community-to-home model designed to prevent that regression.
Design. This was a randomized controlled trial conducted in small-city and rural communities in Oklahoma. All participants first completed a three-month community-based recreational therapy balance program. At the three-month assessment, participants were randomly assigned to either a home-based program with weekly remote coaching or to a control condition receiving general wellness guidance without targeted follow-up.
Intervention. The home-based phase lasted twelve weeks and included a structured exercise manual, video-guided instruction, and weekly remote coaching by telephone. The coaching was intended to reinforce adherence and to address motivation and safety. Adherence was tracked through weekly contact records.
Assessments. Data were collected at baseline, three months, and six months. Gait speed, stride length, and cadence were measured with the GAITRite electronic walkway (CIR Systems, New Jersey, USA). Postural stability was assessed with the BioSway system (Biodex Medical Systems, New York, USA). Secondary outcomes included fall-related self-efficacy (Short Falls Efficacy Scale-International), psychosocial health (Hospital Anxiety and Depression Scale), social connectedness (Lubben Social Network Scale), and quality of life (PDQ-39).
Hypotheses. (1) Participants in the home-based program with remote coaching would show greater improvement in gait velocity, stride length, and balance at six months than the control group. (2) The intervention group would maintain higher adherence and show reduced fear of falling. (3) The intervention group would report improved psychological well-being and social connectedness.
Analysis. A mixed-model repeated-measures analysis of variance was used, with Bonferroni correction for multiple comparisons and effect sizes to evaluate clinical significance.
- Conditions
- Parkinson Disease, Accidental Falls, Postural Balance
- Being tested
- Home-based exercise program with remote checking and coaching, General wellness guidance
- Keywords
- recreational therapy, balance training, fall prevention, home-based exercise, postural stability, rural health
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise program with remote checking and coachingBehavioural
A 12-week home exercise program consisting of a structured exercise manual, video-guided instruction, and weekly remote coaching by telephone to reinforce adherence and address motivation and safety.
General wellness guidanceBehavioural
General wellness information provided after the community-based program, without structured home exercise materials or scheduled follow-up contact.
| Study group | Role | What they receive |
|---|---|---|
| Home-based program with remote coaching | Experimental | Following the 3-month community-based recreational therapy balance program, participants received a 12-week home-based exercise program that included a structured exercise manual, video-guided instruction, and weekly remote coaching by telephone. Assessments were conducted at baseline, 3 months, and 6 months. Receives: Behavioral: Home-based exercise program with remote checking and coaching |
| Control | Active comparator | Following the same 3-month community-based recreational therapy balance program, participants received general wellness guidance without targeted follow-up or remote coaching. Assessments were conducted at baseline, 3 months, and 6 months. Receives: Behavioral: General wellness guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAITRite system
Gait parameters in centimeters per second measured with the GAITRite electronic walkway (CIR Systems, New Jersey, USA). Higher values indicate faster walking.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (5)
BioSway system
Postural stability measured with the BioSway balance system (Biodex Medical Systems, New York, USA). Higher sway values indicate poorer postural stability.
Measured: Baseline, 3 months, 6 months
Change in fall-related self-efficacy measured by the Short Falls Efficacy Scale-International
Seven-item scale scored from 7 to 28. Higher scores indicate greater concern about falling.
Measured: Baseline, 3 months, 6 months
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
Fourteen-item scale scored from 0 to 42. Higher scores indicate greater anxiety and depressive symptoms.
Measured: Baseline, 3 months, 6 months
Change in social connectedness measured by the Lubben Social Network Scale-6
Six-item scale scored from 0 to 30. Higher scores indicate greater social connectedness.
Measured: Baseline, 3 months, 6 months
Change in quality of life measured by the PDQ-39
Parkinson's Disease Questionnaire-39 summary index scored from 0 to 100. Higher scores indicate worse quality of life.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start10 Dec 2025
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants first completed a 3-month community-based recreational therapy balance program. At the 3-month assessment, participants were randomized to a 12-week home-based program with weekly remote coaching or to a control condition receiving general wellness guidance.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Parkinson's Disease Association, Inc
- Responsible party
- Principal investigator, TimPassmore, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859566
- Sponsor's protocol ID
- AS-19-61-OFF
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The IRB-approved protocol and informed consent documents do not include provisions for sharing individual participant data outside the research team. De-identified aggregate results will be reported in peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Recreational Therapy Balance and Fall-Prevention Program for Individuals With Parkinson's Disease in Small Cities
- ClinicalTrials.gov ID
- NCT07859566
- Acronym / sponsor ID
- AS-19-61-OFF
- Conditions
- Parkinson Disease, Accidental Falls, Postural Balance
- Keywords
- recreational therapy, balance training, fall prevention, home-based exercise, postural stability, rural health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- American Parkinson's Disease Association, Inc
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tested whether a home-based exercise program helps older adults with Parkinson's disease keep the improvements they gain from a community balance program.
Participants lived in small towns and rural communities in Oklahoma, where access to movement disorder specialists is limited. All participants first took part in a three-month community-based recreational therapy balance program. At the end of those three months, participants were randomly assigned to one of two groups. One group continued with a home-based program for twelve weeks, which included an exercise manual, instructional videos, and a weekly telephone call from a researcher. The other group received general wellness guidance without follow-up contact.
Participants were assessed three times: before the community program began, at three months, and at six months. The assessments measured walking speed, stride length, and cadence; postural stability; concern about falling; anxiety and depression; social connectedness; and quality of life.
The purpose of the study was to learn whether continued support at home helps people hold onto the gains they make in a community program, and how quickly those gains are lost without that support.
Detailed description
Parkinson's disease is a progressive neurodegenerative disorder. In rural regions, where access to movement disorder specialists is limited, individuals with Parkinson's disease face increased risks of mobility decline, falls, and social isolation. In Oklahoma, 34% of the population lives in rural areas. Although physical activity improves mobility, reduces fall risk, and enhances quality of life, fewer than 30% of individuals with Parkinson's disease exercise regularly. Rural patients face barriers including limited transportation, fear of injury, and a lack of local programs or peer support.
Preliminary pilot work showed short-term gains in gait velocity and balance following supervised training, but these improvements regressed during follow-up without continued support. This study evaluated a hybrid community-to-home model designed to prevent that regression.
Design. This was a randomized controlled trial conducted in small-city and rural communities in Oklahoma. All participants first completed a three-month community-based recreational therapy balance program. At the three-month assessment, participants were randomly assigned to either a home-based program with weekly remote coaching or to a control condition receiving general wellness guidance without targeted follow-up.
Intervention. The home-based phase lasted twelve weeks and included a structured exercise manual, video-guided instruction, and weekly remote coaching by telephone. The coaching was intended to reinforce adherence and to address motivation and safety. Adherence was tracked through weekly contact records.
Assessments. Data were collected at baseline, three months, and six months. Gait speed, stride length, and cadence were measured with the GAITRite electronic walkway (CIR Systems, New Jersey, USA). Postural stability was assessed with the BioSway system (Biodex Medical Systems, New York, USA). Secondary outcomes included fall-related self-efficacy (Short Falls Efficacy Scale-International), psychosocial health (Hospital Anxiety and Depression Scale), social connectedness (Lubben Social Network Scale), and quality of life (PDQ-39).
Hypotheses. (1) Participants in the home-based program with remote coaching would show greater improvement in gait velocity, stride length, and balance at six months than the control group. (2) The intervention group would maintain higher adherence and show reduced fear of falling. (3) The intervention group would report improved psychological well-being and social connectedness.
Analysis. A mixed-model repeated-measures analysis of variance was used, with Bonferroni correction for multiple comparisons and effect sizes to evaluate clinical significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants first completed a 3-month community-based recreational therapy balance program. At the 3-month assessment, participants were randomized to a 12-week home-based program with weekly remote coaching or to a control condition receiving general wellness guidance.
| Arm | Type | Receives |
|---|---|---|
| Home-based program with remote coaching | Experimental | Behavioral: Home-based exercise program with remote checking and coachingFollowing the 3-month community-based recreational therapy balance program, participants received a 12-week home-based exercise program that included a structured exercise manual, video-guided instruction, and weekly remote coaching by telephone. Assessments were conducted at baseline, 3 months, and 6 months. |
| Control | Active comparator | Behavioral: General wellness guidanceFollowing the same 3-month community-based recreational therapy balance program, participants received general wellness guidance without targeted follow-up or remote coaching. Assessments were conducted at baseline, 3 months, and 6 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of Parkinson's disease
- Aged 60 years or older
- Resides in a rural or small-town community in Oklahoma
- Able to participate in a community-based group exercise program
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Medical condition that prevents safe participation in balance exercise
- Unable to attend the community-based sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercise program with remote checking and coachingA 12-week home exercise program consisting of a structured exercise manual, video-guided instruction, and weekly remote coaching by telephone to reinforce adherence and address motivation and safety. | Behavioural | Home-based program with remote coaching |
| General wellness guidanceGeneral wellness information provided after the community-based program, without structured home exercise materials or scheduled follow-up contact. | Behavioural | Control |
Primary outcome
GAITRite system
Time frame: Baseline, 3 months, 6 months
Gait parameters in centimeters per second measured with the GAITRite electronic walkway (CIR Systems, New Jersey, USA). Higher values indicate faster walking.
5 secondary outcomes
BioSway system
Time frame: Baseline, 3 months, 6 months
Change in fall-related self-efficacy measured by the Short Falls Efficacy Scale-International
Time frame: Baseline, 3 months, 6 months
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
Time frame: Baseline, 3 months, 6 months
Change in social connectedness measured by the Lubben Social Network Scale-6
Time frame: Baseline, 3 months, 6 months
Change in quality of life measured by the PDQ-39
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The IRB-approved protocol and informed consent documents do not include provisions for sharing individual participant data outside the research team. De-identified aggregate results will be reported in peer-reviewed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise program with remote checking and coaching and General wellness guidance in people with Parkinson Disease and Accidental Falls, run by Oklahoma State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAITRite system (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.