Design of the muscles in motion study: a randomized controlled trial to evaluate the efficacy and feasibility of an individually tailored home-based exercise training program for children and adolescents with juvenile dermatomyositis

Habers, Esther A; van Brussel, Marco; Langbroek-Amersfoort, Anneli C; van Royen-Kerkhof, Annet; Takken, Tim

doi:10.1186/1471-2474-13-108

Table 2 The primary and secondary study outcomes and the accompanying measurement tools used

From: Design of the muscles in motion study: a randomized controlled trial to evaluate the efficacy and feasibility of an individually tailored home-based exercise training program for children and adolescents with juvenile dermatomyositis

	Items	Range	+/−
Aerobic exercise capacity (Maximal exercise test on treadmill)
VO_2peak [l·min^-1]	na	>0	+
VO_2peak/kg [ml·kg^-1·min^-1] ¹	na	>0	+
O₂ pulse [ml·beat^-1]	na	>0	+
Endurance time [min]	na	>0	+
VO_2VAT [l·min^-1]	na	>0	+
VO_2VAT/kg [ml·kg^-1·min^-1]	na	>0	+
Isometric muscle strength (Hand-held dynamometry – Break method)
Maximal force right knee extensors [N]	na	>0	+
Maximal force left knee extensors [N]	na	>0	+
Maximal force right hip flexors [N]	na	>0	+
Maximal force left hip flexors [N]	na	>0	+
Perception of fatigue (PedsQL Multidimensional Fatigue Scale – patient form)
Total score	18	0-100	+
Subscale General Fatigue score	6	0-100	+
Subscale Sleep/Rest Fatigue score	6	0-100	+
Subscale Cognitive Fatigue score	6	0-100	+
Muscle soreness (10-cm Visual Analogue Scale muscle soreness)
Visual Analogue Scale muscle soreness [cm]	na	0-10	-
Muscle function (BOT-2 Subscale 8 – Strength)
Total score	5	0-42	+
Item Distance standing long jump [m]	na	>0	+
Item Amount of sit-ups in 30 s	na	≥0	+
Item Amount of push-ups in 30 s	na	≥0	+
Item Time wall sit [s]	na	0-60	+
Item Time V-up [s]	na	0-60	+
Muscle function (Childhood Myositis Assessment Scale)
Total score	14	0-52	+
Functional sub maximal aerobic exercise capacity (6-Minute Walk Test)
Distance [m]	na	>0	+
Physical activity enjoyment (Physical Activity Enjoyment Scale)
Total score	17	17-119	+
Quality of life (PedsQL Generic Core Scale – patient form)
Total score	23	0-100	+
Subscale Physical Functioning score	8	0-100	+
Subscale Emotional Functioning score	5	0-100	+
Subscale Social Functional score	5	0-100	+
Subscale School Functioning score	5	0-100	+
Functional ability (Childhood Health Assessment Questionnaire 30 + 8)
Subscale Dressing score	4	0-3	-
Subscale Arising score	2	0-3	-
Subscale Eating score	3	0-3	-
Subscale Walking score	2	0-3	-
Subscale Hygiene score	5	0-3	-
Subscale Reach score	4	0-3	-
Subscale Grip score	5	0-3	-
Subscale Activities score	5	0-3	-
Subscale School/Extracurricular score	8	0-3	-
Disability score [%]	38	0-100	-
Visual Analogue Scale pain [cm]	na	0-10	-
Visual Analogue Scale global disease severity [cm]	na	0-10	-
Physical activity (Actical accelerometer for 7 days)
	na	>0	+
Physical activity (Activity journal for 2 weekdays + 1 Saturday)
Time inactive [%]	na	0-100	-
Time light active [%]	na	0-100	−/+
Time moderate active [%]	na	0-100	−/+
Time vigorous active [%]	na	0-100	+

Abbreviation: na: not applicable.
¹ the primary outcome measure on which power calculation was performed.
+: an increase in value denotes an improvement -: a decrease in value denotes an improvement.

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ISSN: 1471-2474

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