Exercise as Treatment of Fatigue in Parkinson´s Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Aerobic exercise intervention: Participants in this arm are randomized to perform 12 weeks of supervised high intensity progressive aerobic exercise comprising continuous and/or interval cycling-, rowing- or cross-trainer sessions, increasing from 30 minutes towards 60 minutes with intensity increasing from 65 to 90% of individual maximum heart rate. The 12 weeks of aerobic exercise are followed by 12 weeks of habitual lifestyle (follow up period).

Resistance exercise intervention: Participants in this arm are randomized to a 24-week waitlist control group. The control group will continue their habitual lifestyle throughout the 24 weeks. After 24 weeks, the waitlist control group will begin a 12 week supervised resistance exercise intervention 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.

Study 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 (i.e., 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).

Eligibility

Primary outcome measure(s)

• Change in Modified Fatigue Impact Scale — Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only)
  Questionnaire assessing the effects of fatigue on physical, cognitive and psychosocial functioning. The total score of the MFIS is the sum of the scores for the 21 items and ranges from 0 to 84. The ranges of scores for each subscale are as follows: physical, 0 to 36; cognitive, 0 to 40; and psychosocial, 0 to 8. A higher score represents a higher impact of fatigue, in general or in relation to one of the above mentioned areas

Trial sites (1)

More University of Aarhus trials in Denmark

Other trials for the same condition