Cerebellar Ataxia
Conditions
Keywords
ataxia, cerebellar ataxia, exercise, training, rehabilitation
Brief summary
Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods are unknown. The goal of this project is to evaluate how each training method impacts the brain, and particularly, the degenerating cerebellum. Various neuroimaging techniques will be used to accomplish this goal and test the hypothesis that balance training impacts brain structures outside the cerebellum whereas aerobic training causes more neuroplastic changes within the cerebellum.
Detailed description
Degenerative cerebellar diseases are a group of disorders that cause severe disability and can be fatal. There are currently no known disease-modifying treatments available for use, and there is a critical need to find treatments that slow disease progression and allow affected individuals to live more functional lives. Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods have not been thoroughly investigated. It is crucial to understand how the training impacts the brain, and particularly the cerebellum, in order to determine if one training method is better at slowing disease progression than the other. The goal of this proposal is to compare the neural effects of balance versus aerobic training in individuals with degenerative cerebellar diseases. The investigator hypothesizes that aerobic training causes neuroplastic changes within the cerebellum whereas balance training causes improvements for people with cerebellar degeneration by impacting brain structures outside the cerebellum. If this hypothesis is true, aerobic training may have more influence on disease progression than balance training as it directly impacts the cerebellum. To investigate the hypothesis, various neuroimaging techniques will be used. In AIM 1, the investigator will compare cerebellar volume before and after the participants perform either 6-months of balance or aerobic training. In AIM 2, the investigator will investigate whether neural changes have clinical significance by correlating cerebellar volume changes with clinical measures of ataxia. Finally, for AIM 3, the investigator will use diffusion tensor imaging and resting state fMRI scans to examine how both training methods impact cerebellar microstructure and functional cerebellar connections. The investigator hopes that a detailed understanding of how each training method impacts the cerebellum will lead to more targeted training regimens with the goal of slowing disease progression of these devastating diseases.
Interventions
BEHAVIORALAerobic Training
Aerobic training on stationary bike 5x a week for 30 minutes a day.
BEHAVIORALBalance Training
Balance training 5x a week for 30 minutes as instructed by a therapist. Standard of care.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Care providers and outcome assessor will not know which group individuals are assigned. In addition, the primary outcome will be video-recorded and the videos will be scrambled so that outcome assessor will not know if the test was done pre- or post-training.
Intervention model description
This is a single-blinded randomized control trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with spinocerebellar ataxia * Cerebellar atrophy on MRI * Prevalence of ataxia on clinical exam * Ability to safely ride a stationary exercise bike
Exclusion criteria
* Other neurologic conditions * Heart disease * Cognitive impairment * Medical instability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Assessment and Rating of Ataxia (SARA) Score | Baseline, 6 months, 9 months, 12 months | This is to measure ataxia severity. The Scale for the Assessment and Rating of Ataxia (SARA) will be administered before and after training. SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia) - with higher scores indicating more severe ataxia. The scores are based on patient performance of gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements and heel-shin slide. The change in score from baseline to 6 months, 9 months, and 12 months will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index Score | Baseline, 6 months, 9 months, 12 months | The dynamic gait index (DGI) will be performed to assess balance. Patients will be asked to walk 20 feet and conditions such as speed and head position will be varied as previously described. The examiner will then grade the subject's movement on a four-point ordinal scale, ranging from 0 (lowest level of function) to 3 (highest level of function). The total score range is 0 to 24, with higher scores indicating better dynamic balance and functional mobility. |
| Timed Up and Go (TUG) | Baseline, 6 months, 9 months, 12 months | The Timed Up and Go will be performed to assess balance. Once the tester says Go, participants will stand from seated and walk around a cone that is 3 meters away, then walk back to the chair and sit back down. Participants will be timed from the moment the tester says Go until seated again. |
| Fatigue Severity Scale (FSS) Score | Baseline, 6 months, 9 months, 12 months | The FSS is a nine-item questionnaire that measures the severity of fatigue. Each item is rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Scores for all nine items are summed to calculate the total score, which ranges from 9 to 63. Higher scores indicate greater fatigue severity. |
| Quality of Life (QOL) - Physical Health | Baseline, 6 months, 9 months, 12 months | The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation. |
| Quality of Life (QOL) - Psychological | Baseline, 6 months, 9 months, 12 months | The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation. |
| Average Gait Speed | Baseline, 6 months, 9 months, 12 months | This is to measure average time to complete 8-meter walk test. Participants will walk 8 meters as fast as possible three different times. Gait will be reported as meters per second (m/s). |
| Quality of Life (QOL) - Environment | Baseline, 6 months, 9 months, 12 months | The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation. |
| Prevalence of Desired Changes in Diffuse Tensor Imaging | 6 months | Diffusion data will be preprocessed for motion and corrected for geometrical distortion using ExploreDTI. For each participant, the bmatrix will be reoriented to provide a more accurate estimate of diffusion tensor orientations. Diffusion tensor estimation will be performed using a non-linear least square fitting method. FA and Mean Diffusivity (MD) maps will be generated. Whole brain tractography will be performed using all brain voxels with FA ≤ 0.2 as seed region. |
| Prevalence of Cerebellar Volume | Baseline, 6 months, 9 months, 12 months | To determine cerebellar volume, each T1 scan will be visually inspected to ensure inclusion of only minimal movement artifacts. All images will be processed in a blinded manner in order to maintain accuracy and consistency of volume calculation. Regional cerebellar volumes will be calculated using the SUIT toolbox of the SPM12 software. |
| Prevalence of Desired Changes in Resting State fMRI Scans | 6 months | This measure will be a primary outcome for Aim 3. The anatomical and functional data will be pre-processed and analyzed using Statistical Parametric Mapping (SPM12) and the CONN toolbox Version 14p. |
| Quality of Life (QOL) - Social Relationships | Baseline, 6 months, 9 months, 12 months | The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation. |
Countries
United States
Participant flow
Pre-assignment details
64 participants were enrolled. Of those, 2 participants withdrew from the study prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Aerobic Training Participants will be given a stationary exercise bike for home use. They will be instructed to use the exercise bike five times a week for thirty-minute sessions. The exercise intensity prescription will be based on the subject's VO2max determined on pre-test day. The exercise program will start at 60% of intensity per session, and then will be increased by steps of 5% intensity every 2 sessions until participants reach 30 minutes of training at 80% intensity. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance. | 31 |
| Balance Training A physical therapist will tailor a home balance training program for each participant based on pre- training capabilities. Subjects will be asked to perform exercises five times a week for thirty-minute sessions. Both dynamic and static exercises will be performed in sitting and standing positions. Exercises will start with stabilizing in a challenging static position and progress to dynamic arm and leg movements in the same or modified position. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be required to log their exercise effort in terms of frequency and level of balance challenge. | 31 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 6 |
Baseline characteristics
| Characteristic | Balance Training | Total | Aerobic Training |
|---|---|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 13.5 | 54.4 years STANDARD_DEVIATION 12.9 | 55.0 years STANDARD_DEVIATION 12.5 |
| Disease duration | 6.8 years STANDARD_DEVIATION 6.8 | 7.6 years STANDARD_DEVIATION 6.9 | 8.2 years STANDARD_DEVIATION 7 |
| Disease type Idiopathic | 9 Participants | 17 Participants | 8 Participants |
| Disease type multiple system atrophy-cerebellar type | 0 Participants | 2 Participants | 2 Participants |
| Disease type SCA14 | 0 Participants | 1 Participants | 1 Participants |
| Disease type SCA15 | 0 Participants | 1 Participants | 1 Participants |
| Disease type SCA19 | 1 Participants | 1 Participants | 0 Participants |
| Disease type SCA2 | 4 Participants | 9 Participants | 5 Participants |
| Disease type SCA27 | 1 Participants | 1 Participants | 0 Participants |
| Disease type SCA3 | 2 Participants | 6 Participants | 4 Participants |
| Disease type SCA4 | 1 Participants | 2 Participants | 1 Participants |
| Disease type SCA6 | 3 Participants | 8 Participants | 5 Participants |
| Disease type SCA7 | 1 Participants | 1 Participants | 0 Participants |
| Disease type SCA8 | 4 Participants | 6 Participants | 2 Participants |
| Disease type Spinocerebellar ataxia type 1 (SCA1) | 5 Participants | 7 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 31 Participants | 62 Participants | 31 Participants |
| Sex: Female, Male Female | 13 Participants | 29 Participants | 16 Participants |
| Sex: Female, Male Male | 18 Participants | 33 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 8 / 31 | 10 / 31 |
| serious Total, serious adverse events | 2 / 31 | 1 / 31 |
Outcome results
Primary
Change in Assessment and Rating of Ataxia (SARA) Score
This is to measure ataxia severity. The Scale for the Assessment and Rating of Ataxia (SARA) will be administered before and after training. SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia) - with higher scores indicating more severe ataxia. The scores are based on patient performance of gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements and heel-shin slide. The change in score from baseline to 6 months, 9 months, and 12 months will be reported.
Time frame: Baseline, 6 months, 9 months, 12 months
Population: Some participants were lost to follow up at 6 months, 9 months, and 12 months, so data could not be collected from those participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Aerobic Training | Change in Assessment and Rating of Ataxia (SARA) Score | Baseline to 6 months | -2.4 score on a scale |
| Aerobic Training | Change in Assessment and Rating of Ataxia (SARA) Score | Baseline to 9 months | -1.5 score on a scale |
| Aerobic Training | Change in Assessment and Rating of Ataxia (SARA) Score | Baseline to 12 months | -1.4 score on a scale |
| Balance Training | Change in Assessment and Rating of Ataxia (SARA) Score | Baseline to 6 months | -0.9 score on a scale |
| Balance Training | Change in Assessment and Rating of Ataxia (SARA) Score | Baseline to 9 months | -0.2 score on a scale |
| Balance Training | Change in Assessment and Rating of Ataxia (SARA) Score | Baseline to 12 months | 0 score on a scale |
Secondary
Average Gait Speed
This is to measure average time to complete 8-meter walk test. Participants will walk 8 meters as fast as possible three different times. Gait will be reported as meters per second (m/s).
Time frame: Baseline, 6 months, 9 months, 12 months
Population: Some participants were lost to follow up at 6 months, 9 months, and 12 months, so data could not be collected from those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Training | Average Gait Speed | Baseline | 0.90 m/s | Standard Error 0.28 |
| Aerobic Training | Average Gait Speed | 6 months | 0.80 m/s | Standard Error 0.26 |
| Aerobic Training | Average Gait Speed | 9 months | 0.80 m/s | Standard Error 0.26 |
| Aerobic Training | Average Gait Speed | 12 months | 0.80 m/s | Standard Error 0.26 |
| Balance Training | Average Gait Speed | 12 months | 0.79 m/s | Standard Error 0.26 |
| Balance Training | Average Gait Speed | Baseline | 0.95 m/s | Standard Error 0.32 |
| Balance Training | Average Gait Speed | 9 months | 0.80 m/s | Standard Error 0.26 |
| Balance Training | Average Gait Speed | 6 months | 0.89 m/s | Standard Error 0.3 |
Secondary
Dynamic Gait Index Score
The dynamic gait index (DGI) will be performed to assess balance. Patients will be asked to walk 20 feet and conditions such as speed and head position will be varied as previously described. The examiner will then grade the subject's movement on a four-point ordinal scale, ranging from 0 (lowest level of function) to 3 (highest level of function). The total score range is 0 to 24, with higher scores indicating better dynamic balance and functional mobility.
Time frame: Baseline, 6 months, 9 months, 12 months
Population: Some participants were lost to follow up at 6 months, 9 months, and 12 months, so data could not be collected from those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Training | Dynamic Gait Index Score | 6 months | 12.8 score on a scale | Standard Error 2 |
| Aerobic Training | Dynamic Gait Index Score | 12 months | 13.3 score on a scale | Standard Error 2 |
| Aerobic Training | Dynamic Gait Index Score | 9 months | 13.0 score on a scale | Standard Error 2 |
| Aerobic Training | Dynamic Gait Index Score | Baseline | 11.8 score on a scale | Standard Error 2 |
| Balance Training | Dynamic Gait Index Score | 6 months | 13.2 score on a scale | Standard Error 2 |
| Balance Training | Dynamic Gait Index Score | Baseline | 11.7 score on a scale | Standard Error 2 |
| Balance Training | Dynamic Gait Index Score | 9 months | 13.2 score on a scale | Standard Error 2 |
| Balance Training | Dynamic Gait Index Score | 12 months | 12.8 score on a scale | Standard Error 2 |
Secondary
Fatigue Severity Scale (FSS) Score
The FSS is a nine-item questionnaire that measures the severity of fatigue. Each item is rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Scores for all nine items are summed to calculate the total score, which ranges from 9 to 63. Higher scores indicate greater fatigue severity.
Time frame: Baseline, 6 months, 9 months, 12 months
Population: Some participants were lost to follow up at 6 months, 9 months, and 12 months, so data could not be collected from those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Training | Fatigue Severity Scale (FSS) Score | Baseline | 41.2 score on a scale | Standard Error 5.1 |
| Aerobic Training | Fatigue Severity Scale (FSS) Score | 6 months | 33.3 score on a scale | Standard Error 5.2 |
| Aerobic Training | Fatigue Severity Scale (FSS) Score | 9 months | 35.6 score on a scale | Standard Error 5.2 |
| Aerobic Training | Fatigue Severity Scale (FSS) Score | 12 months | 35.3 score on a scale | Standard Error 5.2 |
| Balance Training | Fatigue Severity Scale (FSS) Score | 12 months | 36.2 score on a scale | Standard Error 5.2 |
| Balance Training | Fatigue Severity Scale (FSS) Score | Baseline | 33.5 score on a scale | Standard Error 5.2 |
| Balance Training | Fatigue Severity Scale (FSS) Score | 9 months | 34.8 score on a scale | Standard Error 5.2 |
| Balance Training | Fatigue Severity Scale (FSS) Score | 6 months | 35.0 score on a scale | Standard Error 5.1 |
Secondary
Prevalence of Cerebellar Volume
To determine cerebellar volume, each T1 scan will be visually inspected to ensure inclusion of only minimal movement artifacts. All images will be processed in a blinded manner in order to maintain accuracy and consistency of volume calculation. Regional cerebellar volumes will be calculated using the SUIT toolbox of the SPM12 software.
Time frame: Baseline, 6 months, 9 months, 12 months
Secondary
Prevalence of Desired Changes in Diffuse Tensor Imaging
Diffusion data will be preprocessed for motion and corrected for geometrical distortion using ExploreDTI. For each participant, the bmatrix will be reoriented to provide a more accurate estimate of diffusion tensor orientations. Diffusion tensor estimation will be performed using a non-linear least square fitting method. FA and Mean Diffusivity (MD) maps will be generated. Whole brain tractography will be performed using all brain voxels with FA ≤ 0.2 as seed region.
Time frame: 6 months
Secondary
Prevalence of Desired Changes in Resting State fMRI Scans
This measure will be a primary outcome for Aim 3. The anatomical and functional data will be pre-processed and analyzed using Statistical Parametric Mapping (SPM12) and the CONN toolbox Version 14p.
Time frame: 6 months
Secondary
Quality of Life (QOL) - Environment
The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation.
Time frame: Baseline, 6 months, 9 months, 12 months
Population: Some participants were lost to follow up at 6 months, 9 months, and 12 months, so data could not be collected from those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Training | Quality of Life (QOL) - Environment | Baseline | 65.5 score on a scale | Standard Error 5.7 |
| Aerobic Training | Quality of Life (QOL) - Environment | 6 months | 70.5 score on a scale | Standard Error 5.7 |
| Aerobic Training | Quality of Life (QOL) - Environment | 9 months | 69.5 score on a scale | Standard Error 5.7 |
| Aerobic Training | Quality of Life (QOL) - Environment | 12 months | 68.9 score on a scale | Standard Error 5.7 |
| Balance Training | Quality of Life (QOL) - Environment | 12 months | 72.2 score on a scale | Standard Error 5.7 |
| Balance Training | Quality of Life (QOL) - Environment | Baseline | 68.3 score on a scale | Standard Error 5.7 |
| Balance Training | Quality of Life (QOL) - Environment | 9 months | 69.6 score on a scale | Standard Error 5.7 |
| Balance Training | Quality of Life (QOL) - Environment | 6 months | 66.1 score on a scale | Standard Error 5.7 |
Secondary
Quality of Life (QOL) - Physical Health
The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation.
Time frame: Baseline, 6 months, 9 months, 12 months
Population: Some participants were lost to follow up at 6 months, 9 months, and 12 months, so data could not be collected from those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Training | Quality of Life (QOL) - Physical Health | Baseline | 55.8 score on a scale | Standard Error 7 |
| Aerobic Training | Quality of Life (QOL) - Physical Health | 6 months | 54.3 score on a scale | Standard Error 7.1 |
| Aerobic Training | Quality of Life (QOL) - Physical Health | 9 months | 57.1 score on a scale | Standard Error 7.1 |
| Aerobic Training | Quality of Life (QOL) - Physical Health | 12 months | 57.1 score on a scale | Standard Error 7.1 |
| Balance Training | Quality of Life (QOL) - Physical Health | 12 months | 60.7 score on a scale | Standard Error 7.2 |
| Balance Training | Quality of Life (QOL) - Physical Health | Baseline | 59.1 score on a scale | Standard Error 7.1 |
| Balance Training | Quality of Life (QOL) - Physical Health | 9 months | 59.8 score on a scale | Standard Error 7.2 |
| Balance Training | Quality of Life (QOL) - Physical Health | 6 months | 60.1 score on a scale | Standard Error 7.1 |
Secondary
Quality of Life (QOL) - Psychological
The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation.
Time frame: Baseline, 6 months, 9 months, 12 months
Population: Some participants were lost to follow up at 6 months, 9 months, and 12 months, so data could not be collected from those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Training | Quality of Life (QOL) - Psychological | 9 months | 68.8 score on a scale | Standard Error 7.2 |
| Aerobic Training | Quality of Life (QOL) - Psychological | 6 months | 63.1 score on a scale | Standard Error 7.2 |
| Aerobic Training | Quality of Life (QOL) - Psychological | 12 months | 66.2 score on a scale | Standard Error 7.2 |
| Aerobic Training | Quality of Life (QOL) - Psychological | Baseline | 65.6 score on a scale | Standard Error 7.1 |
| Balance Training | Quality of Life (QOL) - Psychological | 12 months | 66.2 score on a scale | Standard Error 7.2 |
| Balance Training | Quality of Life (QOL) - Psychological | Baseline | 68.1 score on a scale | Standard Error 7.2 |
| Balance Training | Quality of Life (QOL) - Psychological | 6 months | 67.6 score on a scale | Standard Error 7.2 |
| Balance Training | Quality of Life (QOL) - Psychological | 9 months | 67.0 score on a scale | Standard Error 7.2 |
Secondary
Quality of Life (QOL) - Social Relationships
The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation.
Time frame: Baseline, 6 months, 9 months, 12 months
Population: Some participants were lost to follow up at 6 months, 9 months, and 12 months, so data could not be collected from those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Training | Quality of Life (QOL) - Social Relationships | Baseline | 60.1 score on a scale | Standard Error 8.4 |
| Aerobic Training | Quality of Life (QOL) - Social Relationships | 6 months | 65.5 score on a scale | Standard Error 8.4 |
| Aerobic Training | Quality of Life (QOL) - Social Relationships | 9 months | 64.2 score on a scale | Standard Error 8.5 |
| Aerobic Training | Quality of Life (QOL) - Social Relationships | 12 months | 65.4 score on a scale | Standard Error 8.6 |
| Balance Training | Quality of Life (QOL) - Social Relationships | 12 months | 65.7 score on a scale | Standard Error 8.5 |
| Balance Training | Quality of Life (QOL) - Social Relationships | Baseline | 64.8 score on a scale | Standard Error 8.5 |
| Balance Training | Quality of Life (QOL) - Social Relationships | 9 months | 60.1 score on a scale | Standard Error 8.5 |
| Balance Training | Quality of Life (QOL) - Social Relationships | 6 months | 53.0 score on a scale | Standard Error 8.4 |
Secondary
Timed Up and Go (TUG)
The Timed Up and Go will be performed to assess balance. Once the tester says Go, participants will stand from seated and walk around a cone that is 3 meters away, then walk back to the chair and sit back down. Participants will be timed from the moment the tester says Go until seated again.
Time frame: Baseline, 6 months, 9 months, 12 months
Population: Some participants were lost to follow up at 6 months, 9 months, and 12 months, so data could not be collected from those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Training | Timed Up and Go (TUG) | Baseline | 17.0 seconds | Standard Error 3.1 |
| Aerobic Training | Timed Up and Go (TUG) | 6 months | 15.5 seconds | Standard Error 3.1 |
| Aerobic Training | Timed Up and Go (TUG) | 9 months | 15.5 seconds | Standard Error 3.1 |
| Aerobic Training | Timed Up and Go (TUG) | 12 months | 16.8 seconds | Standard Error 3.1 |
| Balance Training | Timed Up and Go (TUG) | 12 months | 16.7 seconds | Standard Error 3.1 |
| Balance Training | Timed Up and Go (TUG) | Baseline | 16.6 seconds | Standard Error 3.1 |
| Balance Training | Timed Up and Go (TUG) | 9 months | 15.7 seconds | Standard Error 3.1 |
| Balance Training | Timed Up and Go (TUG) | 6 months | 15.7 seconds | Standard Error 3.1 |