Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324422
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-07
Brief Title:
Exercise as Treatment of Fatigue in Parkinsons Disease
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Can High-intensity Exercise be Used to Treat Fatigue in Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this study is to test whether 12 weeks of high-intensity aerobic exercise can treat fatigue in Parkinsons disease PD
The study will be a randomized multi-site controlled trial with follow up Clinically fatigued persons with PD will be allocated to either 12 weeks of high-intensity aerobic exercise or to a waitlist control group receiving high-intensity resistance exercise after 24 weeks of habitual lifestyle control period
It is hypothesized that persons with PD receiving 12 weeks of high-intensity aerobic exercise will show superior effects on perceived fatigue ie clinical relevant reductions when compared to the PD control group primary hypothesis and that these effects are sustained after 12-weeks of follow up secondary hypothesis
The study will be a randomized multi-site controlled trial with follow up Clinically fatigued persons with PD will be allocated to either 12 weeks of high-intensity aerobic exercise or to a waitlist control group receiving high-intensity resistance exercise after 24 weeks of habitual lifestyle control period
It is hypothesized that persons with PD receiving 12 weeks of high-intensity aerobic exercise will show superior effects on perceived fatigue ie clinical relevant reductions when compared to the PD control group primary hypothesis and that these effects are sustained after 12-weeks of follow up secondary hypothesis
Detailed Description:
Background
Parkinsons disease PD is a neurodegenerative disorder characterized by progressive and disabling motor and non-motor symptoms Worldwide PD is the fastest growing neurological disorder Medical and surgical approaches in the symptomatic treatment of PD are progressing but currently no disease modifying therapies exist While awaiting effective disease modifying therapies there is a major need to optimise symptomatic treatments of disabling PD symptoms
A recent survey among 678 persons with PD pwPD and 104 carerpartnerfamily members or friends identified Fatigue and energy as the non-motor symptom that if improved would make the most marked difference to their daily lives Fatigue affects 30-70 depending on definition of pwPD and has been associated with worse prognosis depression anxiety poor sleep limited working ability social distancing decreased physical activity and impaired quality of life Nevertheless no effective medical or non-medical treatments exist for fatigue in PD
Generally physical exercise is highly recommended as a symptomatic intervention in PD In a recent survey 19 of pwPD n195 reported exercise as a coping strategy for fatigue and approximately half of the participants 497 n511 reported that exercise improved fatigue However it was not specified whether exercise was used as an acute coping strategy that instantly reducedprevented fatigue or if it was used as a chronic coping strategy where regular exercise sessions reduced the chronic fatigue level In other populations a physical exercise session can acutely lower the perceived fatigue level while increasing the perceived energy level To our knowledge no studies have so far investigated the acute effects of different types of high intensity exercise on fatigue in pwPD
Diverging evidence exists on the effects of regular exercise on fatigue in PD Two thirds of the existing studies cautiously suggest that exercise ie dance aerobic exercise exergaming and mixed modalities can potentially improve perceived fatigue However the last third show no difference or even increased fatigue levels following an exercise intervention These heterogeneous results may be due to poor study designs as only one study applied fatigue as the primary outcome making most existing studies at risk of being underpowered Also none of the studies applied clinical fatigue as an inclusion criterium which might have led to an underestimation of the potential exercise effects Lastly most existing studies were based on small sample sizes ie 30 participants half included no control group and most interventions prescribed exercise with low to moderate intensity rather than higher intensity exercise potentially limiting the effects of the intervention Consequently there is a need for a new PD high intensity exercise study with stronger methodologies assessing the chronic effects on fatigue
Another argument for further evaluation of exercise as a treatment for fatigue in pwPD is based on findings from other neurological disorders such as multiple sclerosis where both aerobic- and resistance exercise effectively reduce self-reported fatigue Nonetheless it remains unclear whether some exercise modalities are more efficient than others at inducing acute and chronic effects making aerobic- and resistance exercise relevant for testing in pwPD
Taken together there is a need to investigate if high-intensity exercise can decrease fatigue in clinically fatigued pwPD both acutely ie effects observed immediately after a single exercise session andor chronically ie the general fatigue level after a period with regular exercise sessions Understanding the efficacy of basic exercise modalities ie aerobic- and resistance exercise and their working mechanisms before applying mixed exercise modalities therefore seems essential in the development of new fatigue management interventions for pwPD
To gain further insight into the effects of high-intensity exercise on fatigue in PD a randomized controlled multi-site trial with a follow up was designed
As the present study may pave the way for introducing exercise in the management of PD fatigue the study poses the potential to change clinical practice for pwPD
The purpose of the mother study is to test the hypotheses that clinically fatigued pwPD receiving aerobic exercise will show superior effects on fatigue ie clinical relevant reductions when compared to a control group primary hypothesis and that these effects are sustained after 12 weeks of follow up secondary hypothesis
Interventions
Aerobic exercise 12 weeks with 2-3 sessions per week of supervised high intensity progressive aerobic exercise are performed comprising continuous andor interval cycling- rowing- or cross-trainer sessions increasing from 30 towards 60 min with intensity increasing from 65 to 90 of individual maximum heart rate
Resistance exercise 12 weeks with 2-3 sessions per week of supervised resistance exercise are performed comprising machine exercises in 3 to 5 sets with 2-3 minutes rest in between and a decrease from 12 to 6 repetitions in parallel with intensity increasing from 15RM repetition maximum to 8 RM
The exercise interventions have previously been used by our research group in neurological populations and are safe and feasible Interventions are allowed to run up to 14 weeks to catch up missing exercise sessions
Outcomes
See the section Outcome Measures for specifications Additionally contact information demographic information health and medication information and a blood sample will be obtained
Statistical considerations
Whilst fatigue has been reported to decrease in pwPD after exercise interventions none of the existing studies have applied the Modified Fatigue Impact Scale MFIS In fatigued persons with multiple sclerosis MFIS 38 points our group has previously shown that the total MFIS score can be substantially reduced following aerobic exercise change scores exercise -1316 vs control -31628 By expecting comparable effects in fatigued pwPD our sample size estimation alpha level 5 beta level 80 revealed that a minimum of 84 pwPD must be enrolled in the study ie n42 for the aerobic exercise group and n42 for the control groupwaitlist resistance exercise group Assuming a dropout of 10 n47 participants are required in each group
Randomization
After baseline assessment of fatigued participants participants will be randomized in a 11 ratio to aerobic exercise or a waitlist control group A computer-generated list of random numbers will be generated in the Research Electronic Data Capture REDCap system The randomization will be stratified by site The outcome assessors will be blinded for the randomization
Perspectives
The findings of this project hold the potential to establish aerobic exercise andor resistance exercise as a safe and accessible treatments of a frequent and disabling PD non-motor symptom namely fatigue In addition the proposed study will expand our current knowledge about the acute effects of exercise on fatigue potentially offering a simple modality to manage fatigue during everyday life Taken together the present study may lay the ground for a yet unexplored area of research with important implications for millions of pwPD clinicians and the society
Parkinsons disease PD is a neurodegenerative disorder characterized by progressive and disabling motor and non-motor symptoms Worldwide PD is the fastest growing neurological disorder Medical and surgical approaches in the symptomatic treatment of PD are progressing but currently no disease modifying therapies exist While awaiting effective disease modifying therapies there is a major need to optimise symptomatic treatments of disabling PD symptoms
A recent survey among 678 persons with PD pwPD and 104 carerpartnerfamily members or friends identified Fatigue and energy as the non-motor symptom that if improved would make the most marked difference to their daily lives Fatigue affects 30-70 depending on definition of pwPD and has been associated with worse prognosis depression anxiety poor sleep limited working ability social distancing decreased physical activity and impaired quality of life Nevertheless no effective medical or non-medical treatments exist for fatigue in PD
Generally physical exercise is highly recommended as a symptomatic intervention in PD In a recent survey 19 of pwPD n195 reported exercise as a coping strategy for fatigue and approximately half of the participants 497 n511 reported that exercise improved fatigue However it was not specified whether exercise was used as an acute coping strategy that instantly reducedprevented fatigue or if it was used as a chronic coping strategy where regular exercise sessions reduced the chronic fatigue level In other populations a physical exercise session can acutely lower the perceived fatigue level while increasing the perceived energy level To our knowledge no studies have so far investigated the acute effects of different types of high intensity exercise on fatigue in pwPD
Diverging evidence exists on the effects of regular exercise on fatigue in PD Two thirds of the existing studies cautiously suggest that exercise ie dance aerobic exercise exergaming and mixed modalities can potentially improve perceived fatigue However the last third show no difference or even increased fatigue levels following an exercise intervention These heterogeneous results may be due to poor study designs as only one study applied fatigue as the primary outcome making most existing studies at risk of being underpowered Also none of the studies applied clinical fatigue as an inclusion criterium which might have led to an underestimation of the potential exercise effects Lastly most existing studies were based on small sample sizes ie 30 participants half included no control group and most interventions prescribed exercise with low to moderate intensity rather than higher intensity exercise potentially limiting the effects of the intervention Consequently there is a need for a new PD high intensity exercise study with stronger methodologies assessing the chronic effects on fatigue
Another argument for further evaluation of exercise as a treatment for fatigue in pwPD is based on findings from other neurological disorders such as multiple sclerosis where both aerobic- and resistance exercise effectively reduce self-reported fatigue Nonetheless it remains unclear whether some exercise modalities are more efficient than others at inducing acute and chronic effects making aerobic- and resistance exercise relevant for testing in pwPD
Taken together there is a need to investigate if high-intensity exercise can decrease fatigue in clinically fatigued pwPD both acutely ie effects observed immediately after a single exercise session andor chronically ie the general fatigue level after a period with regular exercise sessions Understanding the efficacy of basic exercise modalities ie aerobic- and resistance exercise and their working mechanisms before applying mixed exercise modalities therefore seems essential in the development of new fatigue management interventions for pwPD
To gain further insight into the effects of high-intensity exercise on fatigue in PD a randomized controlled multi-site trial with a follow up was designed
As the present study may pave the way for introducing exercise in the management of PD fatigue the study poses the potential to change clinical practice for pwPD
The purpose of the mother study is to test the hypotheses that clinically fatigued pwPD receiving aerobic exercise will show superior effects on fatigue ie clinical relevant reductions when compared to a control group primary hypothesis and that these effects are sustained after 12 weeks of follow up secondary hypothesis
Interventions
Aerobic exercise 12 weeks with 2-3 sessions per week of supervised high intensity progressive aerobic exercise are performed comprising continuous andor interval cycling- rowing- or cross-trainer sessions increasing from 30 towards 60 min with intensity increasing from 65 to 90 of individual maximum heart rate
Resistance exercise 12 weeks with 2-3 sessions per week of supervised resistance exercise are performed comprising machine exercises in 3 to 5 sets with 2-3 minutes rest in between and a decrease from 12 to 6 repetitions in parallel with intensity increasing from 15RM repetition maximum to 8 RM
The exercise interventions have previously been used by our research group in neurological populations and are safe and feasible Interventions are allowed to run up to 14 weeks to catch up missing exercise sessions
Outcomes
See the section Outcome Measures for specifications Additionally contact information demographic information health and medication information and a blood sample will be obtained
Statistical considerations
Whilst fatigue has been reported to decrease in pwPD after exercise interventions none of the existing studies have applied the Modified Fatigue Impact Scale MFIS In fatigued persons with multiple sclerosis MFIS 38 points our group has previously shown that the total MFIS score can be substantially reduced following aerobic exercise change scores exercise -1316 vs control -31628 By expecting comparable effects in fatigued pwPD our sample size estimation alpha level 5 beta level 80 revealed that a minimum of 84 pwPD must be enrolled in the study ie n42 for the aerobic exercise group and n42 for the control groupwaitlist resistance exercise group Assuming a dropout of 10 n47 participants are required in each group
Randomization
After baseline assessment of fatigued participants participants will be randomized in a 11 ratio to aerobic exercise or a waitlist control group A computer-generated list of random numbers will be generated in the Research Electronic Data Capture REDCap system The randomization will be stratified by site The outcome assessors will be blinded for the randomization
Perspectives
The findings of this project hold the potential to establish aerobic exercise andor resistance exercise as a safe and accessible treatments of a frequent and disabling PD non-motor symptom namely fatigue In addition the proposed study will expand our current knowledge about the acute effects of exercise on fatigue potentially offering a simple modality to manage fatigue during everyday life Taken together the present study may lay the ground for a yet unexplored area of research with important implications for millions of pwPD clinicians and the society
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None