Influence of Coaching on Effectiveness, Participation, and Safety of an Exercise Program for Postmenopausal Women with Osteoporosis: A Randomized Trial

Figures & data

Figure 1 Study design and modifications of the study protocol caused by COVID-19 pandemic.

Table 1 Outcome Measures and Time of Assessment

Domain	Instruments	Units	Assessments
			Baseline	Intermediate Follow-Up	Final Follow-Up
Primary and secondary outcome measures
Health Related Quality of Life	Short Osteoporosis Quality of Life Questionnaire (ECOS-16)	Score [best: 1, worst: 5]	X	X	X
Disability	WHO Disability Assessment Schedule (WHODAS)	Score [best: 0, worst: 100]	X	X	X
Fear of falling	Short Falls Efficacy Scale International (Short FES-I)	Score [low: 7–8, moderate: 9–13, high: 14–28]	X	X	X
Weekly Physical Activity	Physical Activity Scale for Elderly (PASE)	Score [inactivity: <42, poor activity: 43–105, moderate activity: 106–145, intense activity: >146]	X	X	X
Physical function measures
Joint Mobility	Shoulders stick test	Cm	X	X	X
	Hip extension goniometry	Degrees [mean of two sides]	X	X	X
	Knee extension goniometry	Degrees [mean of two sides]	X	X	X
	Sit-and-reach test (spine and hamstrings)	Cm [mean of two sides]	X	X	X
Handgrip	Hydraulic Hand Jamar Dynamometer^®	Kg [dominant arm]	X	X	X
Balance	Delos Postural Proprioceptive System^® (Delos S.r.l., Torino): single stance test with eyes open or closed	Score [mean of two sides]	X		X
Functional capacity	6-Minute Walking Test (6MWT)	m	X	X	X

Table 2 Participants’ Baseline Characteristics

			IT [N=26] Mean ± SD or Units	GT [N=26] Mean ± SD or Units	Statistic test	p
Demographic data	Age	Years	68.0 ± 6	67.0 ± 8	Student t	0.487
	Menopause age	Years	49.6 ± 4	50.0 ± 4	Student t	0.760
	Mineral bone density
	Femural Neck	T-Score	−2.5 ± 0.6	−2.5 ± 0.5	Student t	0.911
	Lumbar Spine	T-Score	−2.9 ± 0.7	−3.2 ± 0.7	Student t	0.526
	Occupational Status	Retired or Unemployed	19	19	Chi-square	1.000
		Employed	7	7
	Family Status	Single or Divorced	6	9	Chi-square	0.359
		Married	20	17
	Education	Middle School or Lower	8	6	Chi-square	0.687
		High School Diploma or Higher	18	20
	Weight	Kg	58.0+9	55.7+10	Student t	0.307
	Height	cm	158.1+6	157.6+5	Student t	0.423
	Body Mass Index	Kg/m^2	23.3 ± 3	21.7 ± 8	Student t	0.089
Primary and secondary outcome measures	Short Osteoporosis Quality of Life Questionnaire	Score	1.5 ± 0.5	1.8 ± 0.8	Mann Whitney	0.217
	WHO Disability Assessment Schedule	Score	29.6 ± 5	32.5 ± 8	Mann Whitney	0.140
	Short Falls Efficacy Scale International	Score	8.6 ± 2	9.3 ±3	Mann Whitney	0.361
	History of falls in the previous 3 months	Yes	7	7	Chi-square	1.000
		No	19	19
	Physical Activity Scale for Elderly	Score	178 ± 102	177 ± 97	Mann Whitney	0.978
Physical outcome measures	Shoulders stick test	cm	29.3 ± 30	40.9 ± 37	Student t	0.147
	Hip extension goniometry	Degrees	103.4 ± 13	104.3 ± 13	Student t	0.942
	Knee extension goniometry	Degrees	126.0 ± 12	126.7 ± 9	Student t	0.184
	Sit and reach test	cm	−2.5 ± 7.5	5.6 ± 11*	Student t	0.006
	Handgrip	Kg	23.8 ± 4	21.8 ± 5	Student t	0.639
	Delos Single Stance Test, eye open	Score	85.1 ± 11	84.3 ± 10	Student t	0.934
	Delos Single Stance Test, eye closed	Score	51.3 ± 14	52.9 ± 13	Student t	0.635
	6-Minute Walking Test	m	336.0 ± 51	365.1 ± 69	Student t	0.398

Figure 2 Consort diagram.

Table 3 Primary and Secondary Outcomes Measures

	Groups	Median (IQR*)			Friedman Test
		Baseline Assessment	Intermediate Assessment	Final Assessment	P
Short Osteoporosis Quality of Life Questionnaire (ECOS-16)**	IT	1.7 (0.4)	1.6 (0.8)	1.6 (0.6)	0.720
	GT	1.8 (0.9)	1.8 (0.8)	1.5 (0.8)	0.199
WHO Disability Assessment Schedule (WHODAS)	IT	28.3 (4.9)	29.7 (10.9)	27.9 (5.6)	0.217
	GT	28.7 (5.8)	31.0 (8.1)	29.0 (6.1)	0.158
Short - Falls Efficacy Scale International (Short FES-I)	IT	8 (3)	8 (3)	8 (3)	0.665
	GT	8.1 (1.5)	8 (2.5)	8 (1.5)	0.944
Physical Activity Scale for Elderly (PASE)	IT	142 (90)	171.0 (105.0)	207.7 (140.0)^a	0.006
	GT	161.55 (119.5)	200 (120.8)^a	250 (98.3)^a	0.001

Notes: **Ceiling effect, more than 20% participants had baseline values ≤10% of maximum possible score range. ^a p < 0.05 versus baseline assessment.

Abbreviation: *IQR, Interquartile Range.

Table 4 Physical Outcome Measures

	Groups				Repeated Measures ANOVA
		Baseline Assessment	Intermediate Assessment	Final Assessment	Groups (G)	Assesments (A)	Interaction G*A
		Mean ± SD	Mean ± SD	Mean ± SD	p	p	p
Shoulder stick test	IT	29.3 ± 25.8	7.7 ± 11^a	6.1 ± 10.4^a	0.337	<0.0001	0.487
	GT	31.2 ± 35.3	19.2 ± 35.9	13.4 ± 21.7^a
Hip extension goniometry	IT	105.3 ± 9.9	102.4 ± 11.1	106.2 ± 7.9	0.343	0.289	0.817
	GT	109.1 ± 12.5	106.8 ± 8.7	108.5 ± 10
Knee extension goniometry	IT	126.2 ± 13.3	126.5 ± 9.9	132.2 ± 8.9^a	0.395	<0.0001	0.996
	GT	123.4 ± 7.9	129.3 ± 7.7	134 ± 8.4^a
Sit&Reach Test	IT	−2.2 ± 7.4	0.6 ± 6.5	−1.6 ± 6	0.081	0.519	0.654
	GT	3.0 ± 10.6	3.6 ± 13	1.8 ± 6
Handgrip	IT	23.4 ± 4.4	23.5 ± 3.9	22.7 ± 4	0.840	0.996	0.339
	GT	22.9 ± 3.8	22.7 ± 3.4	23.8 ± 3.8
Delos Single Stance Test: Open Eyes	IT	83.2 ± 12.4		84.8 ±8.5	0.148	0.130	0.649
	GT	86.8 ± 8.2		89.9 ± 2.3
Delos Single stance Test: Closed Eyes	IT	46.0 ± 13		48.8 ± 17.1	0.089	0.107	0.884
	GT	57.3 ± 13		60.6 ± 17.4
6-Minute Walking Test (6MWT)	IT	357.0 ± 57	373.3 ± 83.7	423.9 ± 72.5^a	0.140	<0.0001	0.317
	GT	376.0 ± 83	422.8 ± 28.9^a	458.1 ± 44.2^a

Note: ^a p < 0.05, post hoc tests versus baseline assessment.