Management Programs May Help Keep Fatigue Stable Over Long-term

Fatigue management — whether through a symptom-specific self-management program or through general education regarding managing multiple sclerosis (MS) — may help people with MS in keeping fatigue levels stable in the long term, a recent study suggests.

Indeed, the benefits of such programs were found to remain in effect more than five years later, according to researchers.

“Follow-ups beyond a year for people with a chronic disease, such as MS, are important to understand the long-term effects of both the disease and self-management interventions on associated symptoms,” the investigators wrote.

The study, “A multisite randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Very long term (5–6 year) follow-up at one site,” was published in the Multiple Sclerosis Journal – Experimental, Translational and Clinical.

Fatigue is one of the most common symptoms of MS, affecting about 80% of patients. Defined by mental and/or physical exhaustion that prevents people from engaging in daily activities, fatigue is associated with increased disability, underemployment, and reduced quality of life.

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In an earlier clinical trial (NCT01918800), completed in 2015, researchers at the Oregon Health and Science University compared two different educational programs for people with MS, to determine which had the greatest impact on MS symptoms and quality of life.

The programs were a fatigue self-management course called “Fatigue: Take Control” — known as FTC — and a general MS education control program dubbed “MS: Take Control” (MSTC). Both consisted of six weekly, two-hour small group sessions with trained facilitators.

The trial’s initial results showed no significant differences between the two groups in the first six months after program completion. However, one site, involving 74 patients, showed that the FTC program resulted in lower fatigue scores at one year.

Now, the investigators returned to their study to evaluate the “very long term” effects of the two programs.

“There is little literature on very long term follow-ups after rehabilitation trials,” the team wrote.

The main goal of the original trial had been to investigate if the more symptom-specific FTC program would lead to greater reductions in fatigue than the general education MSTC program.

A total of 204 adults with MS had been enrolled across four Veterans Affairs sites in the U.S. and randomly assigned to one of the programs. Participants were able to walk at least with support from canes or walkers, and had moderate-to-severe fatigue — defined as a score of at least 25 on the modified Fatigue Impact Scale (mFIS), a measure of this symptom’s severity.

While the two programs showed no significant differences in fatigue in mFIS mean scores at completion, or at three or six months follow-up, the one site — which had enrolled more than 36% of the participants — showed “a clinically meaningful improvement compared to baseline [the study’s start] and a statistically significant improvement compared to MSTC participants” at one year.

This delayed effect on fatigue suggested that patients needed a longer follow-up to identify potential benefits from the FTC program.

Thus, researchers decided to conduct a new analysis of patients at this site about five or six years after the program’s completion.

Just over half — 38 — of the initial 74 participants responded to the follow-up request. For the most part, these patients’ baseline characteristics — those found at the study’s start — were the same as those who did not take part in the follow-up. However, the non-respondents had reported greater reductions in their fatigue scores at the six- and 12-month marks.

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After the five or six years, the fatigue scores were found to be similar between groups and were not significantly different from the scores at baseline or at 12 months. The researchers noted that this lack of differences could be explained, at least in part, by the absence of those with the greatest improvements at 12 months.

Changes in behavior — lifestyle changes — that had been implemented by participants after each of their programs also were examined as part of the follow-up. More than half had learned and were using certain behaviors to manage their fatigue, according to the researchers. The most commonly implemented behaviors in both programs were actively prioritizing daily or weekly activities, the follow-up showed.

Of note, there were no differences in the proportion of patients implementing each behavior change in each group, nor in the number of changes.

Overall, “fatigue impact was stable and behavior changes were similar between groups 5–6 years after a fatigue self-management program,” the team wrote.

“While MSTC did not teach specific behavior change strategies to manage fatigue, these strategies are well-known and available, and all were being used with similar frequency in both groups 5–6 years later,” the investigators concluded.

Limitations of the study were its inclusion of few men, and the lack of participant retention, the researchers said, noting that “all follow-ups should be planned at initial trial design.”

“The major strength of this study is that it is the first to evaluate impacts of a multicomponent MS fatigue self-management intervention beyond 12 months,” they wrote.